Product Code: CAF FDA class 2 21 CFR 868.5630

Nebulizer (Direct Patient Interface)

Anesthesiology

The Direct Patient Interface Nebulizer is an anesthesiology device that converts liquid medication into a fine aerosol mist for inhalation directly by the patient, delivering therapeutic agents to the respiratory tract. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification before marketing. The product code is CAF, regulated under 21 CFR 868.5630, within the Anesthesiology medical specialty. No special flags apply to this device.

View on FDA

510(k)s

508

FEI Numbers

189

Registration Numbers

189

Unique Applicants

253

Years Active

Basic Information

Product Code: CAF
Device Class: FDA class 2
Regulation Number: 868.5630
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 508 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260270	FindAir ONE for pMDI (FAO-MDI-V12-GRE-001)	Jun 02, 2026	Substantially Equivalent	FindAir Sp. z o.o.
K251572	eRapid with eTrack System	Dec 19, 2025	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K251659	Mesh Nebulizer (H6)	Nov 14, 2025	Substantially Equivalent	Qingdao Future Medical Technology Co., Ltd.
K244035	Portable mesh nebulizer (JM821)	Sep 19, 2025	Substantially Equivalent	Shenzhen Jermei Medical Device Technology Co., Ltd.
K243468	Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103)	Jul 02, 2025	Substantially Equivalent	Joytech Healthcare Co. , Ltd.
K250022	HeroTracker Sense	Jun 30, 2025	Substantially Equivalent	Voluntis
K250583	AdheResp Smart Breath-actuated Mesh Nebulizer	Jun 20, 2025	Substantially Equivalent	Hcmed Innovations Co., Ltd.
K242354	AllNEB	Apr 29, 2025	Substantially Equivalent	Enchant Tek Co. , Ltd.
K233553	MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter	Jun 18, 2024	Substantially Equivalent	Thayer Medical Corporation
K232507	Aerogen®Solo Nebulizer System	May 10, 2024	Substantially Equivalent	Aerogen, Ltd.
K232523	Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7%	Apr 10, 2024	Substantially Equivalent	Mankind Pharma Limited
K231058	Hudson RCI® AddiPak® Unit Dose Vial	Jan 04, 2024	Substantially Equivalent	Medline Industries, LP
K230379	Portable (Ultrasonic) Nebulizer	Nov 27, 2023	Substantially Equivalent	Dongguan Simzo Electronic Technology Co., Ltd.
K230602	Hudson RCI® TurboMist Nebulizer System	Oct 31, 2023	Substantially Equivalent	Medline Industries, LP
K223367	Ochsner Connected Inhaler Sensor	Aug 30, 2023	Substantially Equivalent	Ochsner Clinic Foundation
K220145	Monaghan medical filtered mouthpiece kit	Aug 24, 2023	Substantially Equivalent	Monaghan Medical Corporation
K223840	eRapid Nebulizer System	Aug 11, 2023	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K223100	Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)	Jun 27, 2023	Substantially Equivalent	Medline Industries, Inc.
K220955	Hudson RCI Variable concentration Large Volume Nebulizer (1770)	Jun 23, 2023	Substantially Equivalent	Medline Industires, Inc.
K222247	Hailie Sensor NF0110	Feb 08, 2023	Substantially Equivalent	Adherium (Nz), Ltd.
K220869	Vapotherm Aerosol Adapter AAA-2	Oct 28, 2022	Substantially Equivalent	Vapotherm, Inc.
K221994	Hailie Sensor NF0107 & NF0108	Oct 04, 2022	Substantially Equivalent	Adherium (Nz), Ltd.
K220622	Hailie Sensor NF0106	Jul 15, 2022	Substantially Equivalent	Adherium (Nz), Ltd.
K212395	Nebulizer	Mar 25, 2022	Substantially Equivalent	Shenzhen Homed Medical Device Co., Ltd.
K211560	Airvo Nebulizer Adapter	Dec 10, 2021	Substantially Equivalent	Fisher & Paykel Healthcare Limited
K210126	Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%	Dec 03, 2021	Substantially Equivalent	The Ritedose Corporation
K203155	BreatheSuite MDI V1	Sep 17, 2021	Substantially Equivalent	Breathesuite, Inc.
K211233	Hailie Sensor NF0109	Aug 18, 2021	Substantially Equivalent	Adherium (Nz), Ltd.
K192971	Nebulizer Kit	Jul 08, 2021	Substantially Equivalent	Excellentcare Medical (Huizhou) , Ltd.
K202171	Pulmogine Vibrating Mesh Nebulizer	Jul 01, 2021	Substantially Equivalent	Hcmed Innovations Co., Ltd.
K203400	Corrugated tube with mouthpiece accessory	Jun 14, 2021	Substantially Equivalent	Trudell Medical International
K201397	Ultrasonic Mesh Nebulizer	Jun 14, 2021	Substantially Equivalent	Shenzhen Ivankaca Technology Co., Ltd.
K201167	AireHealth NebulizerTM	Dec 03, 2020	Substantially Equivalent	Airehealth, Inc.
K182906	Portable Mesh Nebulizer	Sep 27, 2020	Substantially Equivalent	Feellife Health, Inc.
K200063	AeroEclipse* ONE BAN	Jul 17, 2020	Substantially Equivalent	Trudell Medical International
K192633	GUS831 Compressor Nebulizer	May 01, 2020	Substantially Equivalent	Globalcare Medical Technology Co., Ltd.
K192724	Propeller Sensor for Symbicort	Mar 26, 2020	Substantially Equivalent	Reciprocal Labs Corporation
K191270	Proneb Max	Jan 23, 2020	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K183586	CapMedic	Sep 13, 2019	Substantially Equivalent	Cognita Labs, LLC
K182638	Hailie Sensor	Jun 19, 2019	Substantially Equivalent	Adherium (Nz), Ltd.
K182573	Hailie Sensor	Jun 07, 2019	Substantially Equivalent	Adherium (Nz), Ltd.
K181405	Hailie Sensor	Dec 10, 2018	Substantially Equivalent	Adherium (Nz), Ltd.
K180871	Portable Nebulizer	Sep 14, 2018	Substantially Equivalent	Microbase Technology Corporation
K171549	Intelligent Mesh Nebulizer	Aug 31, 2018	Substantially Equivalent	Qingdao Future Medical Technology Co., Ltd.
K180770	Propeller Sensor for Neohaler	Aug 01, 2018	Substantially Equivalent	Reciprocal Labs Corporation
K180407	Smartinhaler	Jul 25, 2018	Substantially Equivalent	Adherium (Nz), Ltd.
K170886	HOMED Mesh Nebulizer	Jun 21, 2018	Substantially Equivalent	Shenzhen Homed Medical Device Co., Ltd.
K173825	MC 300R* Nebulizer	May 02, 2018	Substantially Equivalent	Trudell Medical International
K173310	SmartTouch	Mar 26, 2018	Substantially Equivalent	Adherium (Nz), Ltd.
K173367	MC 300* Nebulizer	Feb 28, 2018	Substantially Equivalent	Trudell Medical International
K170916	Portable Nebulizer	Nov 28, 2017	Substantially Equivalent	Microbase Technology Corporation
K170853	InnoSpire Go	Nov 02, 2017	Substantially Equivalent	Respironics Respiratory Drug Delivery (Uk) , Ltd.
K161586	The JLN-23XX Series Piston Compress Nebulizer (with models JLN-2300AS, JLN-2301AS, JLN-2317AS and JLN-2320AS)	Sep 06, 2017	Substantially Equivalent	Shenzhen Homed Medical Device Co., Ltd.
K163485	SmartTouch	Aug 30, 2017	Substantially Equivalent	Adherium (Nz), Ltd.
K153748	AirLife Misty Finity Nebulizer	May 17, 2017	Substantially Equivalent	Care Fusion
K162041	Airworks Nebulizer pe1200m	May 02, 2017	Substantially Equivalent	Convexity Scientific, LLC
K162785	Velox Nebulizer System	Apr 14, 2017	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K162753	RTC 26-C Inline Aerosol Adapter	Feb 28, 2017	Substantially Equivalent	Instrumentation Industries, Inc.
K161454	Propeller Sensor Model 2015-E	Nov 01, 2016	Substantially Equivalent	Reciprocal Labs Corporation
K153010	Hudson RCI AquaPak Sterile Prefilled Nebulizers	Jul 26, 2016	Substantially Equivalent	Teleflexmedical, Inc.
K152882	Propeller System	Mar 08, 2016	Substantially Equivalent	Reciprocal Labs
K152482	Propeller Sensor Model 2014-R	Mar 04, 2016	Substantially Equivalent	Reciprocal Labs
K142541	POCKET NEB	Jan 22, 2016	Substantially Equivalent	Microvaper Devices
K143719	Aeroneb USB Contoller System	Jul 10, 2015	Substantially Equivalent	Aerogen Limited
K150591	Besmed Reusable Jet Nebulizer	Jun 30, 2015	Substantially Equivalent	Besmed Health Business Corp
K143671	Propeller Model 2014-D Sensor	Jun 19, 2015	Substantially Equivalent	Reciprocal Labs
K142516	Propeller System	May 15, 2015	Substantially Equivalent	Reciprocal Labs Corporation
K142153	HUDSON RCI ADDIPAK UNIT DOSE VIAL, 0.9% FULL NORMAL SALINE SOLUTION, 3ML;5ML;15ML	Apr 29, 2015	Substantially Equivalent	Teleflexmedical, Inc.
K142960	Propeller System 2014-R	Mar 05, 2015	Substantially Equivalent	Reciprocal Labs
K142059	FOX MOBILE	Jan 09, 2015	Substantially Equivalent	Vectura GmbH
K140237	DISPOSABLE NEBULIZER SET	Jan 08, 2015	Substantially Equivalent	Suzhou Weikang Medical Apparatus Co., Ltd.
K141214	AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS	Dec 18, 2014	Substantially Equivalent	Teleflexmedical, Inc.
K133360	AERONEB SOLO; AERONEB SOLO ADAPTER	Oct 17, 2014	Substantially Equivalent	Aerogen, Ltd.
K141140	COMP A-I-R	Sep 30, 2014	Substantially Equivalent	Omron Healthcare, Inc.
K140919	RESPICONNECT ADAPTER	Aug 15, 2014	Substantially Equivalent	Trudell Medical Int'L
K133105	BREEZE NEBULIZER (NBR-10X)	Jun 24, 2014	Substantially Equivalent	Digio2 International Co., Ltd.
K140211	ULTRASONIC MESH NEBULIZER	May 30, 2014	Substantially Equivalent	Foshan Gaunying Electronics Co., Ltd.
K140638	PROPELLER SYSTEM - MODEL 2	May 02, 2014	Substantially Equivalent	Reciprocal Labs Corporation
K133951	SMARTTOUCH	Apr 25, 2014	Substantially Equivalent	Nexus6, Ltd.
K132247	ULTRASONIC MESH NEBULIZER	Jan 08, 2014	Substantially Equivalent	Foshan Gaunying Electronics Co., Ltd.
K123030	COMPRESSOR NEBULIZER MODEL MCN-S600XX	Dec 19, 2013	Substantially Equivalent	Dongguan Aidisy Machinery & Electronic Equipment C
K130379	ROLLINS 7 OXYGEN MASK	Oct 09, 2013	Substantially Equivalent	Rollins Medical Solutions, Inc.
K123527	AIRLIFE	Apr 25, 2013	Substantially Equivalent	Care Fusion
K121770	HEADSTAR MEDICAL SMALL VOLUME JET NEBULIZER	Apr 17, 2013	Substantially Equivalent	Headstar Medical Products Co., Ltd.
K122060	CLEVER TD-7001NEBULIZER	Mar 21, 2013	Substantially Equivalent	Taidoc Technology Corporation
K121520	ULTRASONIC NEBULIZER (MESH TYPE)	Mar 15, 2013	Substantially Equivalent	K-Jump Health Co., Ltd.
K130091	PULMOSAL	Mar 13, 2013	Substantially Equivalent	Pharmacaribe
K123614	SOLARYS VENTILATOR AEROSOL DELIVERY SYSTEM (AS)	Mar 11, 2013	Substantially Equivalent	Trudell Medical Intl.
K121969	U-RIGHT COMPRESSOR NEBULIZER	Feb 28, 2013	Substantially Equivalent	Taidoc Technology Corporation
K122857	HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100	Nov 07, 2012	Substantially Equivalent	Pegasus Research Corp.
K121154	ULTRASONIC NEBULIZER	Aug 20, 2012	Substantially Equivalent	Foshan Gaunying Electronics Co., Ltd.
K111246	SPIRALE DRUG DELIVERY SYSTEM	Aug 10, 2012	Substantially Equivalent	Armstrong Medical , Ltd.
K121609	ASTHMAPOLIS SYSTEM	Jul 02, 2012	Substantially Equivalent	Reciprocal Labs Corporation
K112824	QUALITY LIFE TECHNOLOGIES COMPRESSOR NEBULIZER	Jun 21, 2012	Substantially Equivalent	Quality Life Technologies Co;Ltd
K113033	SODIUM CHLORDE INHALATION SOLUTION, 0.9% USP-3ML	Jun 19, 2012	Substantially Equivalent	Nephron Pharmaceuticals Corp.
K112859	ERAPID NEBULIZER SYSTEM	May 30, 2012	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K120939	AERONEB PRO	Apr 26, 2012	Substantially Equivalent	Aerogen, Ltd.
K120051	SODIUM CHLORIDE INHALATION SOLUTION, 3%, 7%, AND 10%, USP-4ML	Apr 20, 2012	Substantially Equivalent	Nephron Pharmaceuticals Corp.
K112041	KOO SMALL VOLUME NEBULIZER (SVN)	Dec 22, 2011	Substantially Equivalent	Koo (Shanghai) Industries Co., Ltd.
K112564	QUIXIE NEBULIZER	Nov 23, 2011	Substantially Equivalent	Odyssey Medical Technologies
K102454	I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM	Oct 25, 2011	Substantially Equivalent	Respironics Respiratory Drug Delivery (Uk) , Ltd.
K111570	MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR	Sep 29, 2011	Substantially Equivalent	Thayer Medical Corporation
K110860	COMP A-I-R	Sep 02, 2011	Substantially Equivalent	Omron Healthcare, Inc.
K102719	ATLANTEAN TRIGGER NEBULIZER	Jul 01, 2011	Substantially Equivalent	Atlantean Corporation
K110273	AEROVENT PLUS CHC	Jun 09, 2011	Substantially Equivalent	Monaghan Medical Corporation
K103635	CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S	May 13, 2011	Substantially Equivalent	Aerogen, Ltd.
K101552	FOSHAN CARE MEDICAL NEBULIZER MODEL KYWH2001	Mar 14, 2011	Substantially Equivalent	Foshan Care Medical Technology Co., Ltd.
K101953	SMDIA-1000	Jan 07, 2011	Substantially Equivalent	Southmedic, Inc.
K102658	MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS	Dec 10, 2010	Substantially Equivalent	Thayer Medical Corp.
K102240	NIVO NEBULIZER SYSTEM	Nov 10, 2010	Substantially Equivalent	Aerogen Ireland, Ltd.
K101424	PHARMACARIBE INHALED SALINE SOLUTIONS	Aug 17, 2010	Substantially Equivalent	Pharmacaribe
K101857	RTC-24 VP METERED DOSE INHALER ADAPTER, MODEL RTC 24-V	Jul 22, 2010	Substantially Equivalent	Instrumentation Industries, Inc.
K092859	MERITS MODEL N SERIES NEBULIZER COMPRESSORS	Jul 02, 2010	Substantially Equivalent	Merits Health Products Co., Ltd.
K100285	LITETOUCH MASK	Jun 29, 2010	Substantially Equivalent	Respironics New Jersey, Inc.
K092560	PARI SINUS	May 06, 2010	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K100380	ALTERA NEBULIZER SYSTEM, MODEL 678G1002	Feb 22, 2010	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K092918	PARI VIOS	Feb 04, 2010	Substantially Equivalent	Pari Respiratory Equipment, Inc.
K091794	CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202	Jan 28, 2010	Substantially Equivalent	Steve Islava
K091111	RTC METERED DOSE INHALER ADAPTERS-SINGLE PATIENT USE, MODEL RTC 24-V, RTC MDI ADAPTER KIT-SINGLE PATIENT USE, MODEL RTC	Dec 02, 2009	Substantially Equivalent	Instrumentation Industries, Inc.
K090730	AKITA JET	Nov 13, 2009	Substantially Equivalent	Activaero America, Inc.
K091272	BESMED JET NEBULIZER BOTTLE SET	Nov 10, 2009	Substantially Equivalent	Besmed Health Business Corp
K091803	SMARTTRACK SYSTEM	Oct 09, 2009	Substantially Equivalent	Nexus6, Ltd.
K083256	ULTRASONIC NEBULIZER SYSTEM, MODEL KN-9210	Jun 26, 2009	Substantially Equivalent	K-Jump Health Co., Ltd.
K090840	VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.	Jun 25, 2009	Substantially Equivalent	Ventlab Corp.
K090307	DDI ULTRASONIC NEBULIZER SYSTEM	Jun 18, 2009	Substantially Equivalent	Diagnostic Devices, Inc.
K090065	AEROCHAMBER MINI VENTILATION CHAMBER	Apr 09, 2009	Substantially Equivalent	Trudell Medical Intl.
K082878	NEVONI CLASSIC, MODEL 6600-PO	Dec 30, 2008	Substantially Equivalent	Nsr Comercio E Representacoes Ltda
K082541	HEALTHLINE MEDICATOR / REDINEB AEROSOL DRUG DELIVERY SYSTEM	Nov 26, 2008	Substantially Equivalent	Medi Nuclear Corp., Inc.
K081650	AERONEB GO NEBULIZER	Oct 23, 2008	Substantially Equivalent	Aerogen (Ireland), Ltd.
K081738	ULTRASONIC NEBULIZER SYSTEM, MODEL HL100	Sep 17, 2008	Substantially Equivalent	Health & Life Co., Ltd.
K082009	HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS	Aug 22, 2008	Substantially Equivalent	Hsiner Co., Ltd.
K080926	AEROECLIPSE DURABLE BREATH ACTUATED NEBULIZER	Aug 12, 2008	Substantially Equivalent	Trudell Medical Intl.
K080969	HEALTHLINE REDI-NEB MEDICATION NEBULIZER, MODEL RN-510	Jul 25, 2008	Substantially Equivalent	Medi Nuclear Corp., Inc.
K072136	ULTRASONIC NEBULISER MODEL 2010	Jul 15, 2008	Substantially Equivalent	Wilfred Kromker GmbH
K080657	NEB-90 LARGE VOLUME MEDICATION NEBULIZER	Jun 30, 2008	Substantially Equivalent	Medi Nuclear Corp., Inc.
K080230	NEB-U-MASK SYSTEM, MODELS 1895, 1896	Jun 09, 2008	Substantially Equivalent	Teleflexmedical, Inc.
K072163	HAPPYNEB II, HAPPYNEB III, SPEEDY, NEBBY PLUS AND MYNEB, MODEL 5	Mar 06, 2008	Substantially Equivalent	3A Health Care S.R.L.
K072494	AG-CLASSIC	Feb 12, 2008	Substantially Equivalent	Medel S.P.A.
K063716	AEROSOL SYSTEM	Dec 28, 2007	Substantially Equivalent	Amici, Inc.
K072670	MODIFICATION TO: EFLOW ELECTRONIC INHALER/NEBULIZER	Dec 13, 2007	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K072822	FUNHALER, MODEL V-201E	Nov 26, 2007	Substantially Equivalent	Infamed , Ltd.
K072019	AKITA2 APIXNEB	Nov 05, 2007	Substantially Equivalent	Activaero America, Inc.
K070411	AMSURE NEBULIZER	Oct 01, 2007	Substantially Equivalent	Amsino International, Inc.
K072418	OPTICHAMBER ADVANTAGE ANTI-STATIC VALVED HOLDING CHAMBER	Sep 12, 2007	Substantially Equivalent	Respironics New Jersey, Inc.
K072119	AIRLIFE NEBULIZER CAP	Aug 10, 2007	Substantially Equivalent	Cardinalhealth
K062484	FLAEM NUOVA RF6 BASIC AND RF6 PLUS NEBULIZERS	Jun 08, 2007	Substantially Equivalent	Flaem Nuova S.P.A.
K070990	APEX MEDICAL MOBINEB, 9R-027 SERIES	May 18, 2007	Substantially Equivalent	Apex Medical Corp.
K070642	AERONEB PROFESSIONAL NEBULIZER SYSTEM	May 07, 2007	Substantially Equivalent	Aerogen (Ireland), Ltd.
K070498	HYPER SAL	Apr 26, 2007	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K070948	HSINER NEBULIZER BOTTLE	Apr 25, 2007	Substantially Equivalent	Hsiner
K062014	FAMILIES OF MASTER NEB, PRIMO NEB, SC03, NEB AID, 4.2.NEB, Q03, FJ03, AND WALKIE-NEB	Mar 22, 2007	Substantially Equivalent	Flaem Nuova S.P.A.
K063449	DELUXE NEBULIZER	Mar 01, 2007	Substantially Equivalent	Access Point Medical, LLC
K062263	OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22	Feb 23, 2007	Substantially Equivalent	Omron Healthcare, Inc.
K062952	C300 SERIES AIR NEBULIZER COMPRESSOR	Feb 21, 2007	Substantially Equivalent	Choice Smart Health Care Co. , Ltd.
K062689	SIDESTREAM PLUS	Feb 16, 2007	Substantially Equivalent	Respironics , Ltd.
K063103	AG-EDGE, MODEL 91200	Jan 08, 2007	Substantially Equivalent	Medel S.P.A.
K062811	DPILOG, MODEL DPC-512	Dec 20, 2006	Substantially Equivalent	Life Outcomes, Inc.
K062158	LC SPRINT STAR	Aug 28, 2006	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K053490	MERITS HEALTH PRODUCTS PORTABLE NEBULIZER	Jul 24, 2006	Substantially Equivalent	Merits Health Products Co., Ltd.
K060497	BABYAIR	Jul 11, 2006	Substantially Equivalent	Promedic, Inc.
K060404	AG-PLUS, MODEL 91210	Jun 22, 2006	Substantially Equivalent	Medel S.P.A.
K060842	REVJET TURBO	Jun 21, 2006	Substantially Equivalent	Promedic, Inc.
K061381	LC STAR WITH NASAL ADAPTER	Jun 02, 2006	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K060811	OMRON COMPRESSOR SYSTEMS, MODELS NE-C28,NE-C30	May 25, 2006	Substantially Equivalent	Omron Healthcare, Inc.
K060357	TREK S NEBULIZER COMPRESSOR	Apr 05, 2006	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K053360	AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C	Mar 23, 2006	Substantially Equivalent	Aerovectrx Corporation
K060399	LC SPRINT NEBULIZER	Mar 02, 2006	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K053605	AEROECLIPSE II BREATH ACTUATED NEBULIZER	Feb 27, 2006	Substantially Equivalent	Trudell Medical Intl.
K052438	EMG HANDLE NEBULIZER NB02 SERIES	Jan 31, 2006	Substantially Equivalent	Emg Technology Co., Ltd.
K052811	HSINER JET NEBULIZER, MODEL HS-31100	Dec 21, 2005	Substantially Equivalent	Hsiner Co., Ltd.
K053203	MYNEB NEBULIZER, MODEL RDD100	Dec 20, 2005	Substantially Equivalent	Respironics New Jersey, Inc.
K052941	I-NEB INSIGHT AAD SYSTEM	Dec 09, 2005	Substantially Equivalent	Profile Therapeutics Plc
K042991	I-NEB AAD SYSTEM	Sep 23, 2005	Substantially Equivalent	Profile Therapeutics Plc
K051260	SCHUCO MIST AND SCHUCO DELUXE MIST	Sep 15, 2005	Substantially Equivalent	Allied Healthcare Products, Inc.
K050183	SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES	Aug 16, 2005	Substantially Equivalent	Silvestrin Fabris S.R.L.
K051365	COMPRESSOR NEBULIZER SYSTEM, MODEL KN-9321	Jul 22, 2005	Substantially Equivalent	K-Jump Health Co., Ltd.
K043238	COMPRESSOR NEBULIZER, MODEL EMG NBA02-XXX SERIES	Jul 06, 2005	Substantially Equivalent	Emg Technology Co., Ltd.
K051284	MD TURBO	Jun 22, 2005	Substantially Equivalent	Respirics, Inc.
K050104	APEX MEDICAL MININEB & MINIPLUS	Feb 16, 2005	Substantially Equivalent	Apex Medical Corp.
K042483	INVACARE PRO, COMPACT AND PORTABLE DESKTOP	Jan 06, 2005	Substantially Equivalent	Invacare Corporation
K042546	FUNHALER, MODEL FH 101	Jan 03, 2005	Substantially Equivalent	Infamed , Ltd.
K042655	INSPIRATION ELITE NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS456	Oct 13, 2004	Substantially Equivalent	Respironics New Jersey, Inc.
K041079	GUAN HONG ULTRASONIC NEBULIZER, MODEL DR-103/AC-103	Sep 28, 2004	Substantially Equivalent	Guan Hong Enterprise Co., Ltd.
K041082	NEWPORT NEBSONIC N550 ULTRASONIC NEBULIZER	Sep 07, 2004	Substantially Equivalent	Newport Medical Instruments, Inc.
K031370	SHINMED MODE SW-988 UNTRASONIC NEBULIZER	Sep 01, 2004	Substantially Equivalent	Shining World Health Care Co., Ltd.
K041327	MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES	Jul 20, 2004	Substantially Equivalent	Med2000 S.R.L.
K040439	MDI TRIGGER GUARD	Jul 08, 2004	Substantially Equivalent	North American Technical Services (Nats) Corp.
K041418	AIRLIFE MISTY FINITY LARGE VOLUME CONTINUOUS NEBULIZER	Jun 10, 2004	Substantially Equivalent	Cardinalhealth
K032170	TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000	May 28, 2004	Substantially Equivalent	Medical Industries America, Inc.
K030396	OMNI~NEB; OMNI~MAX	May 07, 2004	Substantially Equivalent	B&B Medical Technologies, Inc.
K033833	EFLOW ELECTRONIC INHALER/NEBULIZER	May 05, 2004	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K030747	PRODOSE AAD SYSTEM	Apr 22, 2004	Substantially Equivalent	Profile Therapeutics Plc
K040718	TRUST	Apr 02, 2004	Substantially Equivalent	Dhd Healthcare Corp.
K031982	BIRDSONG LEVERHALER, MODEL LH-1000	Apr 02, 2004	Substantially Equivalent	Birdsong Medical Devices, Inc.
K032516	HIOX80 AEROSOL ADAPTER	Mar 04, 2004	Substantially Equivalent	Sensor Medics Corp.
K032972	AEROCHAMBER MAX VALVED HOLDING CHAMBER	Jan 14, 2004	Substantially Equivalent	Trudell Medical Intl.
K031908	MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)	Jan 14, 2004	Substantially Equivalent	Med2000 S.R.L.
K032849	AERONEB GO NEBULIZER, MODEL AG-AG2000	Nov 21, 2003	Substantially Equivalent	Aerogen, Inc.
K032809	HOSPITAL SPACER	Nov 13, 2003	Substantially Equivalent	Respironics Healthscan, Inc.
K030374	SONIK LDI 20 AIR	Aug 25, 2003	Substantially Equivalent	Evit Labs, Inc.
K023602	SMALL VOLUME NEBULIZER	May 01, 2003	Substantially Equivalent	Allegiance Healthcare Corporation
K021742	GALEMED NEB-EASY NEBULIZER	Oct 25, 2002	Substantially Equivalent	Galemed Corp.
K021443	56 SERIES JET NEBULIZER	Oct 21, 2002	Substantially Equivalent	Project Marketing
K020357	800 SERIES EASYNEB NEBULIZER	Aug 07, 2002	Substantially Equivalent	Nellcor Puritan Bennett, Inc.
K020932	DEVILBISS PULMO-AIDE COMPACT COMPRESSOR	Jun 28, 2002	Substantially Equivalent	Sunrise Medical
K021175	AERONEB PROFESSIONAL NEBULIZER SYSTEM, MODEL#AG-AP6000	May 15, 2002	Substantially Equivalent	Aerogen, Inc.
K020944	VORTEX VALVED HOLDING CHAMBER	May 09, 2002	Substantially Equivalent	Pari Innovative Manufacturers, Inc.
K014056	SALTER LABS MODIFIED NEBUTECH NEBULIZER	Feb 01, 2002	Substantially Equivalent	Salter Labs
K012939	AEROVENT II CHC COLLAPSIBLE HOLDING CHAMBER	Sep 28, 2001	Substantially Equivalent	Monaghan Medical Corp.
K012006	MEDICAL DEPOT POWER NEB 1	Jul 13, 2001	Substantially Equivalent	Medical Depot, Inc.
K002543	COMOACT ULTRASONIC NEBULIZER, MODEL 3060	Jun 14, 2001	Substantially Equivalent	San UP S.A.
K010680	CT SPACER	May 23, 2001	Substantially Equivalent	Clinical Technologies, Inc.
K002831	VEGA ULTRASONIC NEBULIZER	May 23, 2001	Substantially Equivalent	Vega Technologies, Inc.
K003344	MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2	Mar 15, 2001	Substantially Equivalent	Medical Depot, Inc.
K002153	ULTRASONIC NEBULIZER, MODEL NE-520	Mar 13, 2001	Substantially Equivalent	Medisana USA, Inc.
K993101	LITEAIRE	Oct 26, 2000	Substantially Equivalent	Thayer Medical Corp.
K003022	AERONEB PORTABLE NEBULIZER	Oct 13, 2000	Substantially Equivalent	Aerogen, Inc.
K992831	AERONEB II, MODEL APN 200	Aug 25, 2000	Substantially Equivalent	Aerogen, Inc.
K001137	AEROTRACH PLUS VALVED HOLDING CHAMBER (VHC)	Jul 05, 2000	Substantially Equivalent	Trudell Medical Int'L
K000543	CONTEMPRO-MIST	Jun 16, 2000	Substantially Equivalent	Contemporary Products, Inc.
K990435	BESTNEB PORTABLE AEROSOL THERAPY UNIT, AP-100100	Jun 05, 2000	Substantially Equivalent	Apex Medical Corp.
K993492	DEVILBISS NEBULIZER MODEL 800	Apr 21, 2000	Substantially Equivalent	Sunrise Medical Hhg, Inc.
K993199	POCKET CHAMBER VALVED AEROSOL HOLDING CHAMBER	Mar 28, 2000	Substantially Equivalent	Ferraris Medical, Inc.
K994352	SIDE DRAFT NEB-U-MIST NEBULIZER, MODEL 41896	Mar 22, 2000	Substantially Equivalent	Hudson Respiratory Care, Inc.
K990897	NELLCOR PURITAN BENNETT 700 SERIES VENTILATOR SYSTEM, AND EASYNEB NEBULIZER	Mar 15, 2000	Substantially Equivalent	Puritan-Bennett Ireland, Ltd.
K991355	METERED DOSE INHALER ADAPTER-DISPOSABLE, ADAPTER REUSABLE	Jan 27, 2000	Substantially Equivalent	Instrumentation Industries, Inc.
K992285	SALTER AIRE COMPRESSOR	Jan 07, 2000	Substantially Equivalent	Salter Labs
K993558	EZFLOW MAX, MODEL 1007	Nov 12, 1999	Substantially Equivalent	Piper Medical Products
K992722	PRIMEAIRE	Nov 10, 1999	Substantially Equivalent	Thayer Medical Corp.
K992643	MODEL IRC 1001 AEROSOL COMPRESSOR	Oct 27, 1999	Substantially Equivalent	Invacare Corp.
K992986	SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER	Sep 24, 1999	Substantially Equivalent	Salter Labs
K992917	AEROCHAMBER PLUS VALVED HOLDING CHAMBER	Sep 14, 1999	Substantially Equivalent	Trudell Medical Int'L
K992038	POCKETSPACER	Sep 09, 1999	Substantially Equivalent	Ferraris Medical, Inc.
K980024	SHINMED MODEL SW-966 ULTRASONIC NEBULIZER	Sep 03, 1999	Substantially Equivalent	Shining World Health Care Co., Ltd.
K991685	HALOLITE AAD SYSTEM WITH DEDICATED COMPRESSOR	Aug 13, 1999	Substantially Equivalent	Medic-Aid , Ltd.
K991788	SALTER LABS PEP DEVICE	Aug 06, 1999	Substantially Equivalent	Salter Labs
K984085	RITEFLO SPACER	Aug 05, 1999	Substantially Equivalent	Aeromax Technologies, Inc.
K991725	SIDESTREAM NEBULIZER	Jul 30, 1999	Substantially Equivalent	Inspired Medical Products , Ltd.
K990384	EZFLOW CONTINUOUS NEBULIZER,MODEL 1005	Apr 26, 1999	Substantially Equivalent	Piper Medical Products
K982722	AMBU MEDIBAG ADULT, AMBU MEDIBAG INFANT/CHILD	Apr 12, 1999	Substantially Equivalent	Ambu, Inc.
K990185	MDILOG, MODEL MDC-512	Apr 01, 1999	Substantially Equivalent	Medtrak Technologies, Inc.
K990506	MABIS NB-02 ULTRASONIC NEBULIZER	Mar 11, 1999	Substantially Equivalent	Mabis Healthcare, Inc.
K982181	TRUMIST BREATH ACTUATED DISPOSABLE NEBULIZER	Jan 08, 1999	Substantially Equivalent	Trudell Medical
K971981	LS SERIES 200 FLOVISION SYSTEM	Dec 22, 1998	Substantially Equivalent	Systam
K983403	SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER	Dec 17, 1998	Substantially Equivalent	Salter Labs
K981249	METERED DOSE INHALER-REUSABLE MODEL NUMBER RTC 21-A, METERED DOSE INHALER-DISPOSABLE MODEL NUBER RTC 21-D	Nov 23, 1998	Substantially Equivalent	Instrumentation Industries, Inc.
K983736	ICEL EVOLUSONIC PORTABLE ULTRASONIC NEBULIZER	Nov 10, 1998	Substantially Equivalent	Brasamerica Medical Equipment, Inc.
K982043	BRENEB	Nov 09, 1998	Substantially Equivalent	Bremed Italia, S.R.L.
K981772	HALOLITE AAD SYSTEM	Nov 03, 1998	Substantially Equivalent	Medic-Aid , Ltd.
K983002	MYSTIQUE ULTRASONIC NEBULIZER	Oct 16, 1998	Substantially Equivalent	Airsep Corp.
K982179	TRUMIST AIR ENTRAINED DISPOSABLE NEBULIZER	Sep 17, 1998	Substantially Equivalent	Trudell Medical
K982408	AEROTEE, MODEL # 1001	Sep 14, 1998	Substantially Equivalent	Piper Medical Products
K981944	BREATHERITE	Aug 24, 1998	Substantially Equivalent	Ventlab Corp.
K981167	STEALTH PILOT KIT/ STEALTH SPACER/FACE MASK KIT	Jun 18, 1998	Substantially Equivalent	Dhd Healthcare Corp.
K980074	56 SERIES AEROSOL GENERATOR	Jun 12, 1998	Substantially Equivalent	Project Marketing
K980829	3ML STERI-NEB SALINE - 0.9% W/V SODIUM CHLORIDE INHALATION SOLUTION USP	Jun 02, 1998	Substantially Equivalent	Steripak, Ltd.
K980407	HOPE NEBULIZER	May 27, 1998	Substantially Equivalent	B&B Medical Technologies, Inc.
K973532	STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATOR	Mar 19, 1998	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K974379	ULTRANEB	Feb 18, 1998	Substantially Equivalent	Bremed Italia, S.R.L.
K972657	ULTRAMIST 2000	Feb 02, 1998	Substantially Equivalent	Texas Medical Industries, Inc.
K974056	0.9.% SODIUM CHLORIDE INHALATION SOLUTION, USP	Jan 21, 1998	Substantially Equivalent	Holopack International, LP
K973468	MODEL IRC 1199 SCOUT NEBULIZER	Dec 08, 1997	Substantially Equivalent	Invacare Corp.
K970844	ATOMISOR	Nov 13, 1997	Substantially Equivalent	Medical Consulting Service, Inc.
K972778	DEY VIAL SODIUM CHLORIDE 3%	Oct 08, 1997	Substantially Equivalent	Dey Laboratories, Inc.
K971808	SPACE CHAMBER FOR MODEL NUMBER AND ACCESSORIES	Sep 26, 1997	Substantially Equivalent	Monarch Medical
K972467	STERILE WATER FOR INHALATION, USP	Aug 28, 1997	Substantially Equivalent	Holopack International, LP
K972466	SODIUM CHLORIDE INHALATION SOLUTION, USP	Aug 28, 1997	Substantially Equivalent	Holopack International, LP
K972371	ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AIR AND PU 12300 AIR	Aug 19, 1997	Substantially Equivalent	Brasamerica Medical Equipment, Inc.
K970344	MDILOG, MODEL MDC-511	Aug 06, 1997	Substantially Equivalent	Medtrak Technologies, Inc.
K971933	PORT-NEB	Aug 01, 1997	Substantially Equivalent	Medic-Aid , Ltd.
K972237	HAND HELD MEDISPACER	Jul 31, 1997	Substantially Equivalent	Thayer Medical Corp.
K970542	MASTER NEB II	Jun 24, 1997	Substantially Equivalent	Bremed Italia, S.R.L.
K963793	OPTIVENT	Apr 16, 1997	Substantially Equivalent	Health Care Products, Inc.
K970289	COMPRESSOR/NEBULIZER #3650	Apr 15, 1997	Substantially Equivalent	Devilbiss Health Care, Inc.
K970035	JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER, MODEL #JBO-112-009	Apr 01, 1997	Substantially Equivalent	Graham-Field, Inc.
K970010	FPT NEBULIZER	Apr 01, 1997	Substantially Equivalent	Fluid Propulsion Technologies, Inc.
K952910	THE SWIRLER NEBULIZER	Mar 19, 1997	Substantially Equivalent	Amici, Inc.
K962534	THERA-MIST NEBULIZER MODEL-P3000	Feb 28, 1997	Substantially Equivalent	Pegasus Research Corp.
K963917	HOLDEN-WALKER HUMIDIFIER-NEBULIZER KIT	Feb 25, 1997	Unknown	Holden Walker Corp.
K962874	RESPIFLO/S	Feb 25, 1997	Unknown	Curtin & Associates International , Inc.
K962872	RESPIFLO	Feb 25, 1997	Unknown	Tyco Healthcare Deutschaland GmbH
K964994	CPI MODEL 6240 50 PSI NEBULIZER COMPRESSOR	Feb 21, 1997	Substantially Equivalent	Contemporary Products, Inc.
K962438	MISTY OX TURBOHEATER	Jan 13, 1997	Substantially Equivalent	Vital Signs, Inc.
K964078	3050 SPORT-NEB	Jan 10, 1997	Substantially Equivalent	Medical Industries America, Inc.
K960854	SIEMENS SERVO ULTRA NEBULIZER 345	Dec 23, 1996	Substantially Equivalent	Pacesetter, Inc.
K963910	HEART NEBULIZER #100609	Dec 16, 1996	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K963924	LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70	Dec 10, 1996	Substantially Equivalent	Pari Holding Co.
K962879	SALTERLABS 8660 SERIES NEBULIZER	Oct 22, 1996	Substantially Equivalent	Salter Labs
K962822	OPTICHAMBER	Oct 17, 1996	Substantially Equivalent	Healthscan Products, Inc.
K962085	SALTER LABS 8990 SERIES NEBULIZER	Aug 26, 1996	Substantially Equivalent	Salter Labs
K962072	PRONEB TURBO COMPRESSOR MODEL 38V0200	Aug 21, 1996	Substantially Equivalent	Pari Holding Co.
K962161	BAXTER NEBULIZER CAP MODEL 2D0868	Aug 15, 1996	Substantially Equivalent	Baxter Healthcare Corp
K961973	DHD ACE WITH MASK KIT	Aug 15, 1996	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K961476	SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984)	Jul 16, 1996	Substantially Equivalent	Salter Labs
K955104	HIGH FLOW ADJUSTABLE ENTRAINMENT NEBULIZER	Jun 11, 1996	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K960675	WALKHALER PORTABLE COMPRESSOR MODEL 45F70	May 17, 1996	Substantially Equivalent	Pari Holding Co.
K960397	MEDICATOR AEROSOL DRUG DELIVERY SYSTEM	Apr 26, 1996	Substantially Equivalent	Healthline Medical
K955805	DUAL SPRAY MINISPACER	Mar 21, 1996	Substantially Equivalent	Thayer Medical Corp.
K952326	PULMOMIST	Feb 27, 1996	Substantially Equivalent	Global Medical Ent., Inc.
K952249	JET NEBULIZER	Jan 30, 1996	Substantially Equivalent	Devilbiss Health Care, Inc.
K941627	A&D UN-231 ULTRASONIC HANDY NEBULIZER	Dec 28, 1995	Substantially Equivalent	A & D Corporate
K954327	MEDOX CHAMPION COMPACT NEBULIZER	Dec 19, 1995	Substantially Equivalent	Medox Corp.
K952893	THE SWIRLER AEROSOL SYSTEM	Nov 03, 1995	Substantially Equivalent	Amici, Inc.
K933961	MARSAM MODEL 2000 NEBULIZER	Sep 19, 1995	Substantially Equivalent	Marsam Pharmaceuticals, Inc.
K943717	MASTER-NEB NEBULIZER COMPRESSOR SYSTEM	Sep 12, 1995	Substantially Equivalent	Howard K. Mann & Assoc.
K953206	DHD METERED DOSE INHALER (MDI) SPACER (MODIFICATION)	Aug 28, 1995	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K950290	MEDI - PUMP	Aug 24, 1995	Substantially Equivalent	Thomas Industries
K946095	DEVILBISS MODEL 5500	Aug 24, 1995	Substantially Equivalent	Devilbiss Health Care, Inc.
K951259	ICEL ULTRASONIC NEBULIZER MODELS PU 12000 AND PU 12300	Jun 20, 1995	Substantially Equivalent	Impulso Trading Co.
K950867	MEDI - PUMP	Apr 19, 1995	Substantially Equivalent	Thomas Industries
K943990	3000 AEROSOL TWO	Mar 21, 1995	Substantially Equivalent	Medical Industries America, Inc.
K935540	PARI-MASTER MODIFICATION	Mar 17, 1995	Substantially Equivalent	Pari Holding Co.
K944020	AIRSEP NEWLIFE AIR OUTLET OPTION	Mar 16, 1995	Substantially Equivalent	Airsep Corp.
K942444	3002 AEROMAX	Mar 10, 1995	Substantially Equivalent	Medical Industries America, Inc.
K942208	4003 AEROLITE	Feb 24, 1995	Substantially Equivalent	Medical Industries America, Inc.
K950206	FISONEB(R) II	Jan 27, 1995	Substantially Equivalent	Fisons Corp.
K942384	ENDURANCE R3000	Dec 19, 1994	Substantially Equivalent	Essential Medical Supply, Inc.
K942350	CAREPAK	Dec 06, 1994	Substantially Equivalent	Precision Medical, Inc.
K944152	PARI BABY	Nov 18, 1994	Substantially Equivalent	Pari Holding Co.
K943600	UNIHEART	Oct 13, 1994	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K940257	HAND-HELD NEBULIZER	Oct 13, 1994	Substantially Equivalent	Nutec, Inc.
K944643	AUTONEB ACCESSORY CROSS (AAC)	Oct 04, 1994	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K935955	DOSER	Sep 16, 1994	Substantially Equivalent	Newmed Corp.
K935693	AUTONEB BREATH ACTUATED CONTROLLER AND ACCESSORY KIT	Aug 25, 1994	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K934749	FREEWAY LITE NEBULIZER COMPRESSOR	Jul 25, 1994	Substantially Equivalent	Medic-Aid , Ltd.
K921273	EASIMIST ULTRASONIC NEBULIZER	Apr 01, 1994	Substantially Equivalent	Medix Corp.
K926280	STANDARD NEBULIZER HEATER	Mar 22, 1994	Substantially Equivalent	Professional Medical Products, Inc.
K933090	EZ-SPACER	Feb 10, 1994	Substantially Equivalent	Airpharma, LLC
K933535	VENTSTREAM DRUG NEBULIZER	Jan 24, 1994	Substantially Equivalent	Medic-Aid , Ltd.
K930574	AEROCHAMBER W/MASK, MODIFIED	Jan 24, 1994	Substantially Equivalent	Monaghan Medical Corp.
K933915	VENTI-GENTLE-HALER(TM)	Oct 28, 1993	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K923559	STERI-CATH MDI	Oct 25, 1993	Substantially Equivalent	Concord/Portex
K930525	MICRO MIST(TM) NEBULIZER	Sep 29, 1993	Substantially Equivalent	Hudson Respiratory Care, Inc.
K926455	PARI FILTER/VALVE SET	Sep 28, 1993	Substantially Equivalent	Paul Ritzau Pari-Werk GmbH
K924667	AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)	Aug 26, 1993	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K926301	ACE AEROSOL ENHANCER, HAND HELD ORAL INHALATION CO	Jul 21, 1993	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K930949	VOYAGE	Jun 01, 1993	Substantially Equivalent	Mada Medical Products, Inc.
K930947	PROMENADE	Jun 01, 1993	Substantially Equivalent	Mada Medical Products, Inc.
K924649	SOFT-MIST(TM)	May 17, 1993	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K931603	MILLIPORE RT-100 AEROSOL RETENTION FILTER	May 13, 1993	Substantially Equivalent	Sterimatics Co.
K924535	THAYER HAND HELD M.K.I. HOLDING CHAMBER	Mar 10, 1993	Substantially Equivalent	Thayer Medical Corp.
K923888	DEVILBISS MODEL 5650 PULMO-AIDE	Feb 23, 1993	Substantially Equivalent	Devilbiss Health Care, Inc.
K923698	BETAMIST 2	Feb 18, 1993	Substantially Equivalent	Rantran, Inc.
K926055	THE MILLER NEBULIZER SYSTEM	Feb 03, 1993	Substantially Equivalent	Warren C. Miller
K923324	PRECISION MIST COMPRESSOR	Jan 14, 1993	Substantially Equivalent	Precision Medical, Inc.
K924684	MICROFLOW	Dec 15, 1992	Substantially Equivalent	Mountain Medical Equipment, Inc.
K921809	COMPANION 800 PORTABLE NEBULIZER COMPRESSOR (C800)	Dec 04, 1992	Substantially Equivalent	Puritan Bennett Corp.
K913096	SAM SC	Dec 03, 1992	Substantially Equivalent	Ferguson Medical
K913095	SAM LS	Dec 03, 1992	Substantially Equivalent	Ferguson Medical
K922187	COMPACT SPACER	Nov 20, 1992	Substantially Equivalent	Glaxo, Inc.
K924123	SIDESTREAM DISPOSABLE	Nov 16, 1992	Substantially Equivalent	Medic-Aid , Ltd.
K924081	LUMISONIC	Nov 09, 1992	Substantially Equivalent	Lumiscope Co., Inc.
K923690	MINI HEART	Oct 20, 1992	Substantially Equivalent	B&B Medical Technologies, Inc.
K923596	HEART NEBULIZER	Oct 15, 1992	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K921339	HAND-E-BREATH	Oct 01, 1992	Substantially Equivalent	Jerry Mccarty
K923024	NE-U04/NE U04F	Sep 15, 1992	Substantially Equivalent	Omron Healthcare, Inc.
K922923	NE-U07	Sep 15, 1992	Substantially Equivalent	Omron Healthcare, Inc.
K914772	MEDIX NEBULIZING SYSTEM CODE NO. 2000 AND 2001	Jul 24, 1992	Substantially Equivalent	Medix Corp.
K915075	NEBULIZER (DIRECT PATIENT INTERFACE)	Jul 16, 1992	Substantially Equivalent	Medi Nuclear Corp., Inc.
K920443	MININEB	Jul 02, 1992	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K920332	HEART NUBULIZER	May 26, 1992	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K915211	MICROCHAMBER	May 20, 1992	Substantially Equivalent	Respiratory Delivery Systems, Inc.
K914836	OMRON COMPRESSOR NEBULIZER- MODEL NE-C09	May 06, 1992	Substantially Equivalent	Omron Healthcare, Inc.
K914152	SIDESTREAM DRUG NEBULIZER	May 05, 1992	Substantially Equivalent	Medic-Aid , Ltd.
K914465	AUTOCLAVABLE VERSION THERA-MIST NEBULIZER, P32000	Mar 31, 1992	Substantially Equivalent	Pegasus Research Corp.
K914283	THAYER EXPANSION CHAMBER METERED DOSE INHALER	Feb 26, 1992	Substantially Equivalent	Thayer Medical Corp.
K912805	PARI-MASTER	Jan 15, 1992	Substantially Equivalent	Paul Ritzau Pari GmbH
K913326	DHD METERED DOSE INHALER (MDI) SPACER	Jan 07, 1992	Substantially Equivalent	Dhd Diemolding Healthcare Div.
K913316	DEVILBISS MODEL 7427D	Dec 11, 1991	Substantially Equivalent for Some Indications	Devilbiss Health Care, Inc.
K911192	DP 100	Dec 11, 1991	Substantially Equivalent for Some Indications	Ferguson Medical
K913015	HEART NEBULIZER FLOWMETER ADAPTOR	Nov 20, 1991	Substantially Equivalent	B&B Medical Technologies, Inc.
K911807	METERED DOSE INHALER (MDI) SPACER	Oct 23, 1991	Substantially Equivalent	Health Products, Inc.
K911422	DRUG NEBULIZERS	Oct 23, 1991	Substantially Equivalent	Intersurgical, Inc.
K913220	AEROSOL MASKS, 81426, 81476, 81490 & 81492	Oct 10, 1991	Substantially Equivalent	Specialty Packaging Producs, Inc.
K911785	RHINO-GUARD	Oct 07, 1991	Substantially Equivalent	Micromedics, Inc.
K911759	VORTRAN INTERMITTENT SIGNAL ACTIVATED NEBULIZER	Sep 10, 1991	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K912566	MINITROP AEROSOL UNIT	Aug 20, 1991	Substantially Equivalent	Heyer America, Inc.
K913000	HEART NEBULIZER POLE CLAMP	Aug 02, 1991	Substantially Equivalent	B&B Medical Technologies, Inc.
K911896	DEVILBISS MODEL 5000	Jul 31, 1991	Substantially Equivalent	Devilbiss Health Care, Inc.
K904398	WATER COLUMN RELIEF VALVE	Jul 09, 1991	Substantially Equivalent	Icn Pharmaceuticals, Inc.
K904718	AERO-GEN NUBULIZER SYSTEM	Apr 01, 1991	Substantially Equivalent	Tri/Bor Medical, Inc.
K904717	MICRO-VENT NEBULIZER SYSTEM	Apr 01, 1991	Substantially Equivalent	Tri/Bor Medical, Inc.
K903499	MINI-MICRON CIRCUIT	Mar 27, 1991	Substantially Equivalent	Medical Industries America, Inc.
K904716	AERO-GEN NEBULIZER	Jan 02, 1991	Substantially Equivalent	Tri/Bor Medical, Inc.
K904715	OXYGEN/AIR TUBING	Jan 02, 1991	Substantially Equivalent	Tri/Bor Medical, Inc.
K903580	MICRO-MISTER	Dec 27, 1990	Substantially Equivalent	Bp , Ltd.
K904196	MICRO-MIST NEBULIZER	Dec 21, 1990	Substantially Equivalent	Bp , Ltd.
K896375	PREEMICARE NEBUTECH NEBULIZER SYSTEM	Oct 29, 1990	Substantially Equivalent	Preemicare Corp.
K903413	MICROSPACER TM	Oct 09, 1990	Substantially Equivalent	Respiratory Delivery Systems, Inc.
K901315	AEROMIST II NEBULIZER	Sep 10, 1990	Substantially Equivalent	Inhalation Plastics
K900273	TRACH CARE MDI ADAPTER	Aug 29, 1990	Substantially Equivalent	Ballard Medical Products
K896536	PHARMATRONICS NEBULIZER	Jul 23, 1990	Substantially Equivalent	Diversatronics, Inc.
K900783	MDI ADAPTOR	Jul 18, 1990	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K901362	ACCESSORY FITMENT TO NEBULIZER SYSTEM, STERILE	Jun 06, 1990	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K901301	STER INHAL SOLUT PREFIL BTL W/ADJUST ENTRAIN NEBUL	May 31, 1990	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K901114	MEDISONIC HUMDIFIER/INHALER	May 22, 1990	Substantially Equivalent	Medisonic U.S.A., Inc.
K900470	IN-THE NEBULIZER	May 18, 1990	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K900228	H.E.A.R.T. NEBULIZER	Mar 16, 1990	Substantially Equivalent	B&B Medical Technologies, Inc.
K896923	INTERTECH/INSPIRON (R) MEDICATION NEBULIZER KIT	Mar 12, 1990	Substantially Equivalent for Some Indications	Intertech Resources, Inc.
K896984	PARI I.S.-2	Mar 09, 1990	Substantially Equivalent for Some Indications	Dura Pharmaceuticals, Inc.
K896696	(HEART) NEBULIZER	Feb 12, 1990	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K896192	MEDISONIC PNEU-NEB	Jan 03, 1990	Substantially Equivalent	Medisonic U.S.A., Inc.
K895913	STANDARD NEBULIZER HEATER	Dec 22, 1989	Substantially Equivalent	Seamless Div., Professional Medical Products
K894961	MEDISONIC ULTRA-SONIC INHALER	Nov 24, 1989	Substantially Equivalent	Medisonic U.S.A., Inc.
K895231	CATALOG NO. 1755 1S0-NEB, A FILTERED NEBULIZER	Oct 27, 1989	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K894138	MEDIPART DISPOSABLE AEROSOL SYSTEM MP-070-PTD	Sep 26, 1989	Substantially Equivalent	Medipart Jerry Alexander
K893942	THERA-MIST(TM) NEBULIZER, MODEL 30000	Aug 28, 1989	Substantially Equivalent	Pegasus Research Corp.
K884803	AEROCHAMBER M.V.	Apr 26, 1989	Substantially Equivalent	Monaghan Medical Corp.
K884947	HAND HELD NEBULIZER SYSTEM	Feb 17, 1989	Substantially Equivalent	Salter Labs
K882936	ADJUSTABLE ENTRAINMENT NEBULIZER	Jan 09, 1989	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K881648	TRANSFER CONTAINER HUMIDIFIER	Dec 30, 1988	Substantially Equivalent	Newport Biosystems, Inc.
K882935	NEBULIZER HEATER	Dec 27, 1988	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K884359	UNIT DOSE 3% SODIUM CHLORIDE SOLUTION FOR INHALA.	Dec 20, 1988	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K884051	DSM-1 DOSIMETER	Dec 16, 1988	Substantially Equivalent	S & M Instrument Co.
K875134	OMRON ULTRASONIC NEBULIZER NE-U06	Dec 05, 1988	Substantially Equivalent	Nidek, Inc.
K883964	AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER	Nov 30, 1988	Substantially Equivalent	Baxter Healthcare Corp
K882953	HYDRAMED BY LECHLER	Oct 12, 1988	Substantially Equivalent	Lechler, Inc.
K881935	MICROCIRRUS MEDICAL NEBULIZER	Jun 22, 1988	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K880473	AERO-MIST NEBULIZER HEATER	Mar 31, 1988	Substantially Equivalent	Pegasus Research Corp.
K880304	INSPIRON NEBULO BASIC EXTERNAL HEATER	Mar 04, 1988	Substantially Equivalent	Intertech Resources, Inc.
K873521	BRONCHODILATOR TEE - 9056 SERIES	Mar 02, 1988	Substantially Equivalent	Boehringer Laboratories
K880411	DEY-VIAL SODIUM CHLORIDE SOLUTION, USP, STERILE	Feb 29, 1988	Substantially Equivalent	Dey Laboratories, Inc.
K874047	ASTHMAKIT	Feb 29, 1988	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K874082	PORTABLE TRACHEOSTOMY HUMIDIFICATION UNIT	Dec 23, 1987	Substantially Equivalent	800-Air-Wats, Inc.
K874041	DEVILBISS MODEL 8500D	Dec 23, 1987	Substantially Equivalent	The Devilbiss Co.
K874395	RESPIRGARD II NEBULIZER SYSTEM	Dec 21, 1987	Substantially Equivalent	Marquest Medical Products, Inc.
K873930	AEROSOL DELIVERY SYSTEM (AERO-TECH II)	Dec 07, 1987	Substantially Equivalent	Cadema Medical Products, Inc.
K873395	HOYER SOLVET	Oct 20, 1987	Substantially Equivalent	Infrasonics Corp.
K871427	(SPAG) MODEL SPAG-2 6000 SERIES	Oct 06, 1987	Unknown	Viratek, Inc.
K870051	SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE	Oct 06, 1987	Substantially Equivalent	Viratek, Inc.
K872826	ULTRA-NEB 99 ULTRASONIC NEBULIZER	Sep 04, 1987	Substantially Equivalent	The Devilbiss Co.
K871293	SERVO NEBULIZER 945 SIEMENS-ELEMA AB	May 08, 1987	Substantially Equivalent	Siemens Elema AB
K864466	OMRON ULTRASONIC NEBULIZER MODEL NE-UO5	Mar 26, 1987	Substantially Equivalent	Omron Tateisi Electronics Co.
K851436	NEBULAIRE (IRC 1040) NEBULIZER PUMP	Jul 08, 1985	Substantially Equivalent	Invacare Corp.
K851074	VARIABLE NEBULIZER HEATER	Jun 18, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K800023	LUNG AEROSOL UNIT	Jan 01, 1985	Substantially Equivalent	Cadema Medical Products, Inc.
K834077	SINGLE USE NEBULIZER-ADJUST-AIR ENTRAIN	Dec 12, 1983	Substantially Equivalent	Airlife, Inc.
K833922	BRETHANCER, DRUG DELIVERY SYS-INHAL	Dec 08, 1983	Substantially Equivalent	Ciba-Geigy Corp.
K832898	NEBULIZER ACCESSORY FOR SERVO VENTILL	Nov 25, 1983	Substantially Equivalent	Siemens Elema AB
K832086	USE 77 ULTRASONIC NEBULIZER	Jul 19, 1983	Substantially Equivalent	Medlog GmbH Marketing Services
K831270	DISPOS. MEDICATION NEBULIZER	Jun 08, 1983	Substantially Equivalent	Hospitak, Inc.
K831162	ENERGETIC HI-HUM AERSOL UNIT	May 09, 1983	Substantially Equivalent	Energetic Pulmonary
K830943	PREFILLED RESPIRATORY THERAPY VIAL	Apr 28, 1983	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K830895	SINGLE USE NEBULIZER, ADJUST. AIR-	Apr 28, 1983	Substantially Equivalent	Airlife, Inc.
K821129	AIRLIFE NEBULIZER HEATER	May 18, 1982	Substantially Equivalent	Airlife, Inc.
K821191	STER-O-MIST 1000 ML	May 13, 1982	Substantially Equivalent	Inhalation Therapy Equipment, Co.
K820952	OPTI-MIST	Apr 29, 1982	Substantially Equivalent	Corpak Co.
K820227	STER-O-DOSE	Feb 23, 1982	Substantially Equivalent	Inhalation Therapy Equipment, Co.
K810218	PREFILLED NEBULIZER	Mar 04, 1981	Substantially Equivalent	Corpak Co.
K810217	NEBULIZER HEATER	Mar 04, 1981	Substantially Equivalent	Corpak Co.
K802477	MISTY NEBULIZER	Oct 31, 1980	Substantially Equivalent	Airlife, Inc.
K801875	CIRCUITS, BREATHING W/CONNECTORS, ADAPT	Aug 14, 1980	Substantially Equivalent	Airlife, Inc.
K800830	SIEMENS-ELECTROGERATE GMBH MICRO-INHALER	Jun 30, 1980	Substantially Equivalent	Macbeth Sales Corp.
K800562	DISPOSABLE HAND HELD NEBULIZER	Mar 25, 1980	Substantially Equivalent	Intec Medical, Inc.
K800295	0.9% SODIUM CHLORIDE SOL./RESP. THERAPY	Mar 10, 1980	Substantially Equivalent	Abbott Laboratories
K800294	0.45% SODIUM CHLORIDE SOL./RESP. THERAPY	Mar 10, 1980	Substantially Equivalent	Abbott Laboratories
K800083	NEBULIZER TUBING SET	Jan 24, 1980	Substantially Equivalent	Abbott Laboratories
K792364	TEE ADAPTER	Dec 04, 1979	Substantially Equivalent	Airlife, Inc.
K792218	MISTY BEBULIZER	Nov 27, 1979	Substantially Equivalent	Airlife, Inc.
K791820	I.P.P.B. MANIFOLDS & NEB. SING. & DBL	Sep 26, 1979	Substantially Equivalent	Airlife, Inc.
K791536	DISPOSABLE MEDICATION NEBULIZER	Sep 07, 1979	Substantially Equivalent	Hospitak, Inc.
K791445	TWO-PIECE IPPB MANIFOLD MACHINES	Aug 28, 1979	Substantially Equivalent	Airlife, Inc.
K791444	UNIVERSAL TWO-PIECE MACHINES	Aug 28, 1979	Substantially Equivalent	Airlife, Inc.
K791443	TWO-PIECE IPPB MANIFOLD FOR SUPPLY LINE	Aug 28, 1979	Substantially Equivalent	Airlife, Inc.
K791218	INHALATION OPERATED NEBULIZER CODE	Jul 30, 1979	Substantially Equivalent	Travenol Laboratories, S.A.
K790892	MISTY NEBULIZER	Jul 24, 1979	Substantially Equivalent	Airlife, Inc.
K791089	SHERWOOD NEBULIZER KIT	Jul 10, 1979	Substantially Equivalent	Sherwood Medical Co.
K790982	INSPIRON NEBULO TM 28 NEBULIZER KIT	Jun 27, 1979	Substantially Equivalent	C.R. Bard, Inc.
K791042	I.P.P.B. MANIFOLD & NEBULIZER, UNIVERSAL	Jun 13, 1979	Substantially Equivalent	Airlife, Inc.
K790926	NEBULIZER WITH MOUTHPIECE AND TEE	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790925	NEBULIZER WITH 4-WAY T NO M-174	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790924	NEBULIZER NO. M-175	May 21, 1979	Substantially Equivalent	Mem Medical, Inc.
K790154	MANIFOLD, FOR DOUBLE SUPPLY	Mar 07, 1979	Substantially Equivalent	Airlife, Inc.
K790153	MANIFOLD, W/CORRUGATED TUBING	Mar 07, 1979	Substantially Equivalent	Airlife, Inc.
K790152	MANIFOLD, UNIVERSAL I.P.P.B	Mar 07, 1979	Substantially Equivalent	Airlife, Inc.
K781485	PATIENT CIRCUIT MANIFOLD	Oct 16, 1978	Substantially Equivalent	Bourns Medical Systems, Inc.
K781542	HEATED NEBULIZER	Oct 10, 1978	Substantially Equivalent	Chemetron Medical Products, Inc.
K781467	U-FLOAT VALVE 2D9023	Sep 07, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780668	SOLUTIONS FOR RESPIRATORY THERAPY	Jun 13, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780456	NEBULIZER HEATER	Apr 12, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780406	2C7153 NEBULIZER CAP	Apr 12, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780119	NEBULIZER, DISP, 2D0815	Apr 03, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780264	NEBULIZATION KIT & ADAPTER KIT	Mar 09, 1978	Substantially Equivalent	Chesebrough-Pond'S U.S.A. Co.
K772296	INSPIRON MANIFOLD	Jan 17, 1978	Substantially Equivalent	C.R. Bard, Inc.
K772295	INSPIRON MANIFOLD (SINGLE)	Jan 17, 1978	Substantially Equivalent	C.R. Bard, Inc.
K772294	INSPIRON MANIFOLD (DOUBLE)	Jan 17, 1978	Substantially Equivalent	C.R. Bard, Inc.
K772348	NEBULIZER ADAPTER	Jan 03, 1978	Substantially Equivalent	Respiratory Care, Inc.
K772222	NEBULIZER SET-2C7105	Dec 22, 1977	Substantially Equivalent	Travenol Laboratories, S.A.
K772072	MANIFOLD & NEBU. FOR DOUB. LINE MACH.	Nov 15, 1977	Substantially Equivalent	Inspiron Corp.
K772071	MANIFOLD & NEBU. FOR SINGLE LINE MACH.	Nov 15, 1977	Substantially Equivalent	Inspiron Corp.
K772070	VENTILATOR SETUP, VOLUME	Nov 15, 1977	Substantially Equivalent	Inspiron Corp.
K772068	MANIFOLD & NEBULIZER, UNIVERSAL	Nov 15, 1977	Substantially Equivalent	Inspiron Corp.
K771550	MRT DISPENSOR	Sep 20, 1977	Substantially Equivalent	Mcgaw Respiratory Therapy
K771105	NEBULIZER, MOLEL 503, PART #17068	Jul 05, 1977	Substantially Equivalent	Hospal Medical Corp.
K771061	ODUFLEX AEROSOL SET	Jul 05, 1977	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K770664	NEBULIZER	Jul 05, 1977	Substantially Equivalent	J & S Industries, Inc.
K770828	NEBULIZER HEATER	May 23, 1977	Substantially Equivalent	Ohio Medical Products
K770633	BRACKET BE 122-1	May 23, 1977	Substantially Equivalent	Instrumentation Industries, Inc.
K761300	NEBULIZER CONTROL UNIT	Dec 30, 1976	Substantially Equivalent	Mcgaw Respiratory Therapy
K761299	DISPOSABLE NEBULIZER	Dec 30, 1976	Substantially Equivalent	Mcgaw Respiratory Therapy
K761298	PRE-FILLED DISPOSABLE NEBULIZER	Dec 30, 1976	Substantially Equivalent	Mcgaw Respiratory Therapy
K760964	ADDI-MIST	Dec 09, 1976	Substantially Equivalent	Respiratory Care, Inc.
K760845	SOLO-SPHERE HEATER	Oct 27, 1976	Substantially Equivalent	Respiratory Therapy
K760585	U-MID PREFILLED NEBULIZER	Oct 15, 1976	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K760489	NEBULIZER, HANDHELD (T UP-DRAFT)	Sep 03, 1976	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K760442	NEBULIZER ADAPTER (AERMIST)	Aug 26, 1976	Substantially Equivalent	Aerway Laboratories, Inc.
K760335	NEBULIZER, MICRO (ADDI-MIST)	Aug 11, 1976	Substantially Equivalent	Respiratory Care, Inc.
K760095	RESPIRIZOR	Jul 20, 1976	Substantially Equivalent	Campillary Systems