Product Code: BZD FDA class 2 21 CFR 868.5905

Ventilator, Non-Continuous (Respirator)

Anesthesiology

The Ventilator, Non-Continuous (Respirator) is a ventilator designed to assist breathing on a non-continuous or intermittent basis, supporting patients with periodic respiratory compromise rather than continuous mechanical ventilation. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is BZD, regulated under 21 CFR 868.5905 in the Anesthesiology specialty.

View on FDA

510(k)s

450

FEI Numbers

109

Registration Numbers

109

Unique Applicants

138

Years Active

Basic Information

Product Code: BZD
Device Class: FDA class 2
Regulation Number: 868.5905
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 450 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243583	F&P Nova Nasal Mask	Jun 18, 2025	Substantially Equivalent	Fisher & Paykel Healthcare Limited
K250624	myAir	May 28, 2025	Substantially Equivalent	ResMed Corp
K243023	WiZARD 520 Full Face Mask	May 23, 2025	Substantially Equivalent	Wellell Inc.
K242547	AirFit F20 Mask System; AirFit F20 NM Mask System	May 19, 2025	Substantially Equivalent	ResMed Pty Ltd
K242935	Respiration Data Management Software (PAP Link PC)	Jan 15, 2025	Substantially Equivalent	BMC Medical Co., Ltd.
K243225	Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)	Dec 31, 2024	Substantially Equivalent	Genadyne Biotechnologies, Inc.
K241830	Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask	Oct 18, 2024	Substantially Equivalent	Sleepnet Corporation
K241939	EasyCare Tx 2	Sep 27, 2024	Substantially Equivalent	ResMed Corp
K241216	myAir	Sep 26, 2024	Substantially Equivalent	ResMed Corp
K234134	AirFit F30i Mask System; AirFit F30i NM Mask System; Arcadia Mask System	Sep 24, 2024	Substantially Equivalent	ResMed Pty Ltd (Registration Number: 3004604967)
K233829	Nova Micro Pillows Mask Small A Model (NVP1SA); Nova Micro Pillows Mask Medium A Model (NVP1MA); Nova Micro Pillows Mask Large A Model (NVP1LA); Nova Micro Pillows Mask Fit Pack/SML A Model (NVP1SMLA); Nova Micro Pillows Mask Small Sleep Lab A (NVP1SSLA); Nova Micro Pillows Mask Medium Sleep Lab A (NVP1MSLA); Nova Micro Pillows Mask Large Sleep Lab A (NVP1LSLA); Nova Micro Pillows Mask Fit Pack Sleep Lab A (NVP1SMLSLA)	Aug 23, 2024	Substantially Equivalent	Fisher and Paykel Healthcare Limited
K233555	AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask	Jul 31, 2024	Substantially Equivalent	Philips Respironics
K241661	Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask	Jul 10, 2024	Substantially Equivalent	Sleepnet Corporation
K233415	DELTAWAVE Nasal Pillows System	Jul 02, 2024	Substantially Equivalent	RemSleep Holdings
K241469	iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask	Jun 15, 2024	Substantially Equivalent	Sleepnet Corporation
K230476	Oran Park Mask	Oct 19, 2023	Substantially Equivalent	ResMed Pty Ltd (Registration Number: 3004604967)
K231313	Therapy Mask 3100 NC/SP	Jul 28, 2023	Substantially Equivalent	Respironics Inc.
K223747	Whitsundays Mask System	Jul 06, 2023	Substantially Equivalent	ResMed Pty Ltd (Registration Number: 3004604967)
K221436	F&P 950 Accessory Breathing Circuit Kits	Jun 29, 2023	Substantially Equivalent	Fisher & Paykel Healthcare Ltd
K223696	F&P Solo Mask Range	May 17, 2023	Substantially Equivalent	Fisher & Paykel Healthcare Ltd
K212263	Luna G3 BPAP System	Mar 25, 2022	Substantially Equivalent	3B Medical, Inc.
K212371	F&P Evora Full Face Mask	Mar 18, 2022	Substantially Equivalent	Fisher & Paykel Healthcare Ltd
K211155	Auto CPAP System	Mar 09, 2022	Substantially Equivalent	BMC Medical Co., Ltd.
K211274	iQ 2 Nasal Mask, Phantom 2 Nasal Mask	Jan 10, 2022	Substantially Equivalent	Sleepnet Corporation
K210844	DreamWear Silicone Pillows Mask	Aug 24, 2021	Substantially Equivalent	Respironics, Inc.
K210386	Magneto Nasal Mask	Jul 12, 2021	Substantially Equivalent	Respironics, Inc.
K203347	Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask	Jul 02, 2021	Substantially Equivalent	Suzhou Yuyue Medical Technology Co., Ltd.
K203601	Innova Nasal Non-Vented Mask	Apr 30, 2021	Substantially Equivalent	Sleepnet Corporation
K201620	Luna® G3 BPAP 25A	Jan 29, 2021	Substantially Equivalent	3B Medical, Inc.
K200565	Galapogos	Jan 17, 2021	Substantially Equivalent	ResMed Corp
K203126	S10 Kirra	Dec 18, 2020	Substantially Equivalent	ResMed Pty Ltd
K192177	SysMed S/T	Nov 25, 2020	Substantially Equivalent	SysMed (China) Co., Ltd
K193206	WiZARD 510 Nasal Mask	Oct 29, 2020	Substantially Equivalent	Apex Medical Corp.
K201439	Ventilator, Non-continuous (Respirator)	Sep 25, 2020	Substantially Equivalent	Respironics, Inc.
K200480	DreamStation 2 System, DreamStation 2 Advanced System	Jul 10, 2020	Substantially Equivalent	Respironics, Inc.
K200089	F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model	Jun 02, 2020	Substantially Equivalent	Fisher & Paykel Healthcare Ltd.
K183226	Care Orchestrator Essence	Oct 18, 2019	Substantially Equivalent	Respironics Inc.
K190713	F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large)	Oct 11, 2019	Substantially Equivalent	Fisher & Paykel Healthcare Ltd.
K190254	Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask	Jul 05, 2019	Substantially Equivalent	Sleepnet Corporation
K182394	WiZARD 310/320 Series CPAP Mask	May 17, 2019	Substantially Equivalent	Apex Medical Corp.
K183512	Moore Park Mask	May 07, 2019	Substantially Equivalent	ResMed Ltd
K181053	Care Orchestrator	Jan 04, 2019	Substantially Equivalent	Respironics Inc.
K180388	Transcend 365 miniCPAP System	Nov 30, 2018	Substantially Equivalent	Somnetics International, Inc.
K173193	F&P SleepStyle	Aug 08, 2018	Substantially Equivalent	Fisher & Paykel Healthcare Ltd
K180497	Scone Mask	Jun 15, 2018	Substantially Equivalent	ResMed Ltd
K172335	Bleep DreamPort	Mar 30, 2018	Substantially Equivalent	snapCPAP
K170924	AirFit F20	Jan 03, 2018	Substantially Equivalent	ResMed Ltd
K171212	AirFit N20	Sep 28, 2017	Substantially Equivalent	ResMed Ltd
K163464	Viva Nasal Mask (Model: NM4), Numa Full Face Mask (Model: BMC-FM2)	Sep 05, 2017	Substantially Equivalent	BMC MEDICAL.,LTD.
K162905	SleepWeaver 3D Nasal Mask	Mar 15, 2017	Substantially Equivalent	Circadiance, LLC
K161686	F&P InfoSmart	Jan 24, 2017	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE LTD.
K161412	F&P Brevida Nasal Pillows Mask	Jan 18, 2017	Substantially Equivalent	Fisher & Paykel Healthcare Ltd.
K160836	Menai System	Dec 15, 2016	Substantially Equivalent	ResMed Ltd
K161978	AirFit N20	Nov 17, 2016	Substantially Equivalent	ResMed Ltd
K160127	iCodeConnect	Nov 10, 2016	Substantially Equivalent	3B MEDICAL, INC.
K153505	F&P Eson 2 Nasal Mask	Sep 20, 2016	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE LIMITED
K160822	S9 VPAP Adapt, VPAP Adapt, AirCurve 10 ASV	Sep 09, 2016	Substantially Equivalent	RESMED LTD
K153387	Luna CPAP and Auto CPAP System	Sep 08, 2016	Substantially Equivalent	3B MEDICAL, INC.
K153563	AirFit F20	May 13, 2016	Substantially Equivalent	RESMED LTD.
K153673	AirFit N20	May 02, 2016	Substantially Equivalent	ResMed Ltd
K151120	Simple T Pediatric Nasal Mask	Apr 15, 2016	Substantially Equivalent	RESPIRONICS, INC.
K151683	SleepWeaver Advance Pediatric Nasal CPAP Mask	Apr 05, 2016	Substantially Equivalent	Circadiance, LLC
K152810	DeVilbiss DV6WM Wireless Modem	Jan 21, 2016	Substantially Equivalent	DeVilbiss Healthcare, LLC
K152356	Sapphire	Jan 08, 2016	Substantially Equivalent	RESPIRONICS INC.
K150639	AF541 EE Full Face Mask	Sep 18, 2015	Substantially Equivalent	RESPIRONICS, INC.
K143677	DeVilbiss Intellipap2/DeVilbiss BLUE	Sep 18, 2015	Substantially Equivalent	DeVilbiss Healthcare, LLC
K150111	Apex Medical Corp. iCH CPAP with PVA 9S-007XXX Series	Sep 15, 2015	Substantially Equivalent	APEX MEDICAL CORP.
K150685	Skynector CPAP Mask	Aug 24, 2015	Substantially Equivalent	SKY WISE MEDICAL INSTRUMENT (SHEN ZHEN) CO., LTD.
K143700	CPAP Cannulaide	Aug 05, 2015	Substantially Equivalent	Salter Labs
K150365	Cloud9 System	Jul 21, 2015	Substantially Equivalent	inSleep Technologies, LLC
K143603	Darlinghurst Vented, Darlinghurst NV-AAV	May 21, 2015	Substantially Equivalent	RESMED LTD.
K141770	LUNA CPAP AND AUTO-CPAP SYSTEM	Apr 22, 2015	Substantially Equivalent	3B MEDICAL, INC
K140980	TI NASAL MASK	Feb 10, 2015	Substantially Equivalent	RESPIRONICS, INC.
K140580	REVOLUTION FULLFACE MASK	Jan 16, 2015	Substantially Equivalent	RESPIRONICS INC. (DBA PHILIPS RESPIRONICS)
K142554	Revolution Full Face Mask	Jan 09, 2015	Substantially Equivalent	Respironics, Inc.
K140268	SIMPLE T YOUTH NASAL MASK	Oct 20, 2014	Substantially Equivalent	RESPIRONICS, INC.
K141152	ADVANTAGE	Oct 17, 2014	Substantially Equivalent	STEVENSON INDUSTRIES, INC.
K140929	Z1 CPAP SYSTEM	Oct 17, 2014	Substantially Equivalent	HUMAN DESIGN MEDICAL, LLC
K141522	APEX MEDICAL CORP. ICH CPAP WITH PVA 9S-007XXX SERIES	Oct 06, 2014	Substantially Equivalent	APEX MEDICAL CORP.
K133769	3B RESMART BPAP 25A, BMC RESMART BPAP 25A	Aug 25, 2014	Substantially Equivalent	3B MEDICAL, INC
K140880	DEVILBISS SMARTLINK II SYSTEM	Aug 04, 2014	Substantially Equivalent	DEVILBISS HEALTHCARE LLC
K140279	S9 GREENHILLS	Jul 31, 2014	Substantially Equivalent	RESMED LTD.
K140159	S9 WANDA VPAP ST	Jun 17, 2014	Substantially Equivalent	RESMED LTD.
K132901	AIRSOFT F15	Jun 09, 2014	Substantially Equivalent	RESMED LTD.
K140054	RESCAN	May 16, 2014	Substantially Equivalent	RESMED LTD
K140124	S9 ELOUERA	May 12, 2014	Substantially Equivalent	RESMED CORP
K133009	NASAL MASK, NASAL MASK, FULL FACE MASK	Apr 23, 2014	Substantially Equivalent	BMC MEDICAL CO., LTD
K132606	S9 CRONULLA FOR HER	Jan 13, 2014	Substantially Equivalent	RESMED LTD.
K130828	K SERIES CPAP SYSTEMS	Jan 13, 2014	Substantially Equivalent	CURATIVE MEDICAL INC.
K131901	IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2	Dec 23, 2013	Substantially Equivalent	3B MEDICAL, INC
K132887	AIRFIT N10	Dec 20, 2013	Substantially Equivalent	RESMED LTD.
K132967	3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP	Dec 06, 2013	Substantially Equivalent	3B MEDICAL, INC
K131702	K SERIES CPAP SYSTEMS	Dec 06, 2013	Substantially Equivalent	CURATIVE MEDICAL INC.
K132168	BRONCHOSCOPY ELBOW	Nov 20, 2013	Substantially Equivalent	RESPIRONICS, INC.
K132013	SWIFT AIR	Oct 21, 2013	Substantially Equivalent	RESMED LTD.
K131982	REMSTAR AUTO A-FLEX HT	Oct 18, 2013	Substantially Equivalent	RESPIRONICS, INC.
K132127	TRANSCEND AUTO	Oct 17, 2013	Substantially Equivalent	SOMNETICS INTERNATIONAL, INC.
K130686	NASAL COMFORT FREEDOM	Oct 16, 2013	Substantially Equivalent	LAKEVIEW SLEEP CENTER
K131502	SEATTLE - PAP	Oct 11, 2013	Substantially Equivalent	SEATTLE CHILDRENS HOSPITAL
K130663	BESTFIT2 NASAL MASK	Sep 27, 2013	Substantially Equivalent	CURATIVE MEDICAL INC.
K131707	3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS	Aug 22, 2013	Substantially Equivalent	3B MEDICAL, INC
K121642	WIZARD 230 NASAL PILOW MASK	Jun 06, 2013	Substantially Equivalent	APEX MEDICAL CORP.
K130328	F&P SIMPLUS FULL FACE MASK	Jun 05, 2013	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE LIMITED
K130481	SLEEPWEAVER ANEW FULL FACE SOFT CLOTH PAP MASK	May 24, 2013	Substantially Equivalent	CIRCADIANCE LLC
K130077	REMSTAR SE	May 21, 2013	Substantially Equivalent	RESPIRONICS, INC.
K130037	BREATHE CPAP SYSTEM	May 17, 2013	Substantially Equivalent	BREATHE TECHNOLOGIES, INC.
K123789	SWIFT FX NANO	Mar 29, 2013	Substantially Equivalent	RESMED LTD.
K121747	FACEFIT AND FACEFIT PORTED NON-INVASIVE VENTILATION MASKS	Mar 14, 2013	Substantially Equivalent	INTERSURGICAL INCORPORATED
K123897	K SERIES CPAP SYSTEMS	Mar 13, 2013	Substantially Equivalent	CURATIVE MEDICAL INC.
K122847	KANGAROO NASAL MASK	Mar 06, 2013	Substantially Equivalent	RESPIRONICS INC.
K123979	QUATTRO AIR	Feb 27, 2013	Substantially Equivalent	RESMED LTD.
K121374	ZI BLOWER	Feb 22, 2013	Substantially Equivalent	DESHUM MEDICAL
K112079	APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720	Dec 06, 2012	Substantially Equivalent	APEX MEDICAL CORP.
K121321	HARD SHELL VENTED NASAL MASK	Nov 30, 2012	Substantially Equivalent	SLEEPNET CORPORATION
K121692	MINIME 2 NASAL MASK	Nov 05, 2012	Substantially Equivalent	SLEEPNET CORPORATION
K122350	TAP PAP NASAL PILLOW MASK	Nov 01, 2012	Substantially Equivalent	AIRWAY MANAGEMENT, INC.
K121705	GEO	Oct 23, 2012	Substantially Equivalent	RESMED LTD.
K122769	REMSTAR SE	Oct 09, 2012	Substantially Equivalent	RESPIRONICS, INC.
K121631	SIMPLE T NASAL MASK	Oct 05, 2012	Substantially Equivalent	RESPIRONICS, INC.
K121597	ESON NASAL MASK	Oct 02, 2012	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE LIMITED
K120463	MOJO, VERASEAL	Jul 27, 2012	Substantially Equivalent	SLEEPNET CORPORATION
K120562	PERFORMAX PEDIATRIC EE TOTAL FACE MASK	Jul 17, 2012	Substantially Equivalent	RESPIRONICS, INC.
K120920	HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA	Jul 16, 2012	Substantially Equivalent	HSINER COMPANY
K120285	K SERIES CPAP SYSTEM WITH HEATED HUMIDIFER	Jul 02, 2012	Substantially Equivalent	CURATIVE MEDICAL INC.
K113801	VPAP ADAPT	May 25, 2012	Substantially Equivalent	RESMED CORP
K120035	APEX MEDICAL ICH CPAP SERIES (9S-007XXX)	May 16, 2012	Substantially Equivalent	APEX MEDICAL CORP.
K110629	RESMART CPAP, RESMART AUTO-CPAP AND RESMART HUMIDIFIER	Apr 27, 2012	Substantially Equivalent	3B PRODUCTS, INC.
K120757	SLEEPWEAVER ELAN NASAL CPAP MASK	Apr 24, 2012	Substantially Equivalent	CIRCADIANCE LLC
K113780	EASYCARE TX SYSTEM (CONNEXUNS)	Apr 20, 2012	Substantially Equivalent	RESMED LTD.
K120145	SIMPLE T NASAL MASK	Mar 30, 2012	Substantially Equivalent	RESPIRONICS INC.
K120027	PILAIRO NASAL PILLOWS MASK	Feb 23, 2012	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE LIMITED
K112271	3B WILLOW	Feb 16, 2012	Substantially Equivalent	3B PRODUCTS, LLC
K113127	MIRAGE QUATTRO	Jan 06, 2012	Substantially Equivalent	RESMED LTD.
K113068	REMSTAR AUTO A-FLEX HT	Dec 16, 2011	Substantially Equivalent	RESPIRONICS, INC.
K112489	SWIFT FX BELLA	Dec 07, 2011	Substantially Equivalent	RESMED LTD.
K112220	DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL	Nov 22, 2011	Substantially Equivalent	DEVILBISS HEALTHCARE LLC
K112393	TASMAN	Nov 16, 2011	Substantially Equivalent	RESMED LTD.
K112167	SOYALA SILKGEL FULL FACE MASK	Nov 16, 2011	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K103434	3B FLEX-LITE	Oct 13, 2011	Substantially Equivalent	3B PRODUCTS, LLC
K110471	BABI PLUS INFANT NASAL CANNULA SYSTEM	Oct 07, 2011	Substantially Equivalent	A PLUS MEDICAL
K110316	INFOSEND GSM	Aug 19, 2011	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K110383	BABI*PLUS PRESSURE RELIEF MANIFOLD - 10CM H20, 12.5CM H20, 15CM H20	Aug 01, 2011	Substantially Equivalent	A PLUS MEDICAL
K110884	EASYFIT SILKGEL NASAL MASK	Jul 12, 2011	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K111148	S8 ASPEN WITH H4I PLUS	Jun 30, 2011	Substantially Equivalent	RESMED CORP.
K102625	VEGA CPAP SYSTEM/HEATED HUMIDIFIER, MODEL CP-03	Jun 10, 2011	Substantially Equivalent	VEGA TECHNOLOGIES, INC.
K110405	TRUBLUE NASAL MASK	Jun 06, 2011	Substantially Equivalent	RESPIRONICS, INC.
K102317	IQ VENTILATION NASAL MASK	May 17, 2011	Substantially Equivalent	SLEEPNET CORPORATION
K103174	APEX MEDICAL WIZARD SERIES CPAP MASK	May 06, 2011	Substantially Equivalent	APEX MEDICAL CORP.
K103410	NEOPAP SYSTEM	Mar 30, 2011	Substantially Equivalent	CHILDRENS MEDICAL VENTURES LLC
K103786	ZEST PETITE NASAL MASK	Mar 24, 2011	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K103395	PERFORMAX TOTAL FACE MASK	Mar 24, 2011	Substantially Equivalent	RESPIRONICS, INC.
K102586	S9 VPAP ADAPT WITH H5I	Mar 18, 2011	Substantially Equivalent	RESMED LTD.
K110444	MIRAGE MICRO	Mar 16, 2011	Substantially Equivalent	RESMED LTD.
K102515	NP15	Mar 11, 2011	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K110008	GOLIFE NASAL MASK	Feb 17, 2011	Substantially Equivalent	RESPIRONICS, INC.
K102513	S9 VPAP ST WITH H5I	Jan 05, 2011	Substantially Equivalent	RESMED LTD.
K102746	MIRAGE FX	Dec 28, 2010	Substantially Equivalent	RESMED LTD.
K102502	GOLIFE NASAL MASK	Dec 22, 2010	Substantially Equivalent	RESPIRONICS, INC.
K102224	PIXI PEDIATRIC MASK	Dec 10, 2010	Substantially Equivalent	RESMED LTD.
K100011	FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM	Oct 08, 2010	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K100121	MODEL 300157 CPAP SYSTEM	Jul 13, 2010	Substantially Equivalent	AEIOMED, INC.
K100772	MIRAGE MICRO MODEL 16333 (S), 16334 (M&L), 16335 (LW & XL)	Jun 09, 2010	Substantially Equivalent	RESMED LTD.
K093716	BABI PLUS INFANT NASAL CANNULA SYSTEM	May 13, 2010	Substantially Equivalent	A PLUS MEDICAL
K094040	F&P ICON SERIES CPAP	Apr 27, 2010	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K100343	PAP-CAP	Apr 23, 2010	Substantially Equivalent	PUR-SLEEP, INC.
K093124	PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03	Mar 10, 2010	Substantially Equivalent	CARDINAL HEALTH 207, INC.
K093684	EASYCARE ONLINE	Feb 26, 2010	Substantially Equivalent	RESMED LTD.
K092835	COMFORTGEL NASAL MASK	Feb 12, 2010	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K090804	NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD	Nov 05, 2009	Substantially Equivalent	INNOMED TECHNOLOGIES INC./RESPCARE INC.
K092362	SLEEPWEAVER NASAL CPAP MASK	Nov 02, 2009	Substantially Equivalent	CIRCADIANCE LLC
K092026	EASYCARE TX, TX LINK	Oct 02, 2009	Substantially Equivalent	RESMED LTD.
K091947	S8 ASPEN WITH H4I PLUS	Sep 28, 2009	Substantially Equivalent	RESMED LTD.
K091919	DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST	Sep 28, 2009	Substantially Equivalent	SUNRISE MEDICAL
K091843	COMFORT TWIN NASAL MASK	Sep 10, 2009	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K091066	COMFORT TWIN NASAL MASK	Sep 03, 2009	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K091319	REMSTAR AUTO A-FLEX	Aug 03, 2009	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K091129	QUATTRO LT	Aug 03, 2009	Substantially Equivalent	RESMED LTD.
K090935	MINIME PEDIATRIC MASK	Jul 01, 2009	Substantially Equivalent	SLEEPNET CORPORATION
K091271	RESPIRONICS PERFORMAX TOTAL FACE MASK	May 29, 2009	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K091112	RESPIRONICS SLEEPEASY CPAP SYSTEM	May 15, 2009	Substantially Equivalent	RESPIRONICS, INC.
K090243	REMSTAR M-SERIES AUTO WITH AFLEX CPAP SYSTEM	May 08, 2009	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K090490	MIRAGE ECHO	May 06, 2009	Substantially Equivalent	RESMED CORP.
K083656	APEX MEDICAL XT AUTO CPAP 9S-005200	Apr 22, 2009	Substantially Equivalent	APEX MEDICAL CORP.
K090244	SWIFT FX	Apr 13, 2009	Substantially Equivalent	RESMED LTD.
K082558	COMFORTLITE NASAL MASK	Mar 25, 2009	Substantially Equivalent	RESPIRONICS, INC.
K083816	RES TRAXX ONLINE, MODEL: R14	Mar 20, 2009	Substantially Equivalent	RESMED LTD.
K083832	ZEST NASAL MASK	Mar 16, 2009	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K082866	REVOLUTIONFULL FACE MASK	Jan 30, 2009	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K082605	VPAP AUTO WITH HUMIDAIRE 3I	Jan 13, 2009	Substantially Equivalent	RESMED LTD.
K082983	RESSCAN-PRO	Jan 02, 2009	Substantially Equivalent	RESMED LTD.
K082979	S8 ADVANCE	Jan 02, 2009	Substantially Equivalent	RESMED LTD.
K082209	DEVILBISS DV5M SMARTLINK SYSTEM	Oct 28, 2008	Substantially Equivalent	SUNRISE MEDICAL
K082237	PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST	Oct 09, 2008	Substantially Equivalent	MALLINCKRODT DEVELOPPEMENT FRANCE
K081321	MODIFICATION TO MIRAGE MICRO	Oct 09, 2008	Substantially Equivalent	RESMED LTD.
K081029	SLEEPSTYLE 200 AUTO SERIES HC254	Sep 12, 2008	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K080209	FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK	Sep 12, 2008	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K080516	LAMIN AIR	Jun 23, 2008	Substantially Equivalent	REMGENIC LLC
K080439	SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE	May 16, 2008	Substantially Equivalent	MALLINCKRODT DEVELOPPEMENT FRANCE
K071915	CPAP MASK	May 14, 2008	Substantially Equivalent	ARCIMED LABORATORIES LLC
K081014	SOYALA GEL VENTED	May 09, 2008	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K073600	COMFORTGEL FULL FACE MASK	Apr 25, 2008	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K080079	S8 ESCAPE II	Apr 08, 2008	Substantially Equivalent	RESMED LTD.
K080131	VPAP ST	Apr 01, 2008	Substantially Equivalent	RESMED LTD.
K073673	SOYALA FULL FACE MASK GEL VENTED	Mar 28, 2008	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K073638	SWIFT LT	Mar 20, 2008	Substantially Equivalent	RESMED LTD.
K072993	REUSABLE HEADREST WITH NASAL SEAL	Feb 08, 2008	Substantially Equivalent	AEIOMED, INC.
K071149	HRI 6500, 6600 AND 6700 SERIES V2MASKS	Feb 01, 2008	Substantially Equivalent	HANS RUDOLPH, INC.
K072615	TXCONTROL	Jan 04, 2008	Substantially Equivalent	RESMED LTD.
K072996	REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM	Dec 27, 2007	Substantially Equivalent	RESPIRONICS, INC.
K072592	PERFORMAX TOTAL FACE MASK	Dec 19, 2007	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K072009	WEINMANNCOMPACT, MODEL WM 27380; WEINMANNCLICK2, MODEL WM 27340	Dec 14, 2007	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K072940	MIRAGE MICRO	Dec 13, 2007	Substantially Equivalent	RESMED LTD.
K072755	GALEMED CPAP MASK	Nov 16, 2007	Substantially Equivalent	GALEMED CORP.
K071808	MIRAGE MICRO	Oct 10, 2007	Substantially Equivalent	RESMED LTD.
K071773	CPAP NASAL MASK WITH PILLOWS	Sep 12, 2007	Substantially Equivalent	LIFESOURCE
K071575	SANDMAN INTRO	Sep 10, 2007	Substantially Equivalent	MALLINCKRODT DEVELOPPEMENT FRANCE
K071689	DEVILBISS INTELLIPAP MODEL DV 5 SERIES	Sep 07, 2007	Substantially Equivalent	SUNRISE MEDICAL
K071163	WEINMANNCOMFORT 2, MODEL WM 27600 AND WEINMANNAQUA, MODEL WM 27603	Jul 18, 2007	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K070746	RESTRAXX DATA CENTRE, MODEL R10	Jul 13, 2007	Substantially Equivalent	RESMED LTD.
K071171	VPAP AUTO WITH H3I	Jul 10, 2007	Substantially Equivalent	RESMED LTD.
K071069	MINI CPAP DEVICE AND HUMIDIFIER ACCESSORY	Jun 12, 2007	Substantially Equivalent	VIASYS SLEEP SYSTEMS, LLC.
K070609	APEX MEDICAL XT1 CPAP, MODEL 9S-005	May 04, 2007	Substantially Equivalent	APEX MEDICAL CORP.
K070321	TWILIGHT FULL FACE MASK	Apr 30, 2007	Substantially Equivalent	INVACARE CORP.
K063501	KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US	Apr 06, 2007	Substantially Equivalent	MALLINCKRODT DEVELOPPEMENT FRANCE
K063830	REMSTAR AFLEX CPAP SYSTEM	Mar 09, 2007	Substantially Equivalent	RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP
K063268	CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235	Feb 23, 2007	Substantially Equivalent	HSINER CO., LTD.
K063122	MIRAGE QUATTRO FULL FACE MASK	Feb 02, 2007	Substantially Equivalent	RESMED LTD.
K063011	MIRAGE LIBERTY FULL FACE MASK	Feb 02, 2007	Substantially Equivalent	RESMED LTD.
K063476	BREAS ISLEEP 20I	Jan 22, 2007	Substantially Equivalent	BREAS MEDICAL AB
K063036	OPUS HC482 DIRECT NASAL MASK	Dec 22, 2006	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K061653	SOYALA FULL FACE MASK	Nov 09, 2006	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K062291	VPAP MALIBU WITH H2I	Sep 08, 2006	Substantially Equivalent	RESMED LTD.
K061874	INVACARE'S TWILIGHT II NASAL MASKS	Sep 05, 2006	Substantially Equivalent	INVACARE CORP.
K061236	FLEXIFIT HC432 FULL FACE MASK	Aug 29, 2006	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K060657	ISLEEP BY BREAS, MODELS ISLEEP 10, ISLEEP 20.	Aug 18, 2006	Substantially Equivalent	BREAS MEDICAL AB
K062224	RESPCARE HYBRID AV MASK	Aug 17, 2006	Substantially Equivalent	RESPCARE INC.
K061099	BREATHX NASAL PILLOW AND MASK SYSTEM, MODEL 011-0003	Aug 11, 2006	Substantially Equivalent	HOFFMAN LABORATORIES, LLC
K061200	PRESTIGE CPAP FLOW GENERATOR WITH PRESTIGE HUMIDIFIER	Jul 20, 2006	Substantially Equivalent	RESMED LTD.
K060067	MASKMEDIC CONCEPT NASAL MASK	Jul 14, 2006	Substantially Equivalent	MASKMEDIC
K061057	BREAS ISLEEP 20+	Jun 23, 2006	Substantially Equivalent	BREAS MEDICAL AB
K061034	BIPAP PLUS M-SERIES BI-LEVEL SYSTEM	Jun 23, 2006	Substantially Equivalent	RESPIRONICS, INC.
K060405	SOYALA, SOYALA BLUE	Jun 21, 2006	Substantially Equivalent	WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG
K060273	SLEEPNET MOJO FULL FACE MASK -SMALL, MODEL NO. 53835, MEDIUM ,MODEL NO.53836,LARGE,MODEL NO. 53837	May 02, 2006	Substantially Equivalent	SLEEPNET CORPORATION
K053352	COMFORTLITE NASAL MASK	Feb 15, 2006	Substantially Equivalent	RESPIRONICS, INC.
K053205	RES TRAXX DATA CENTER	Feb 03, 2006	Substantially Equivalent	RESMED LTD.
K053486	TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET	Jan 04, 2006	Substantially Equivalent	HOFFRICHTER GMBH
K052597	BREATHEX OMEGA CPAP DEVICE, MODEL 322	Dec 16, 2005	Substantially Equivalent	HOFFMAN LABORATORIES, LLC
K052249	UTOPIA	Dec 07, 2005	Substantially Equivalent	RESPCARE INC.
K051226	AIRLIFE NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE (NCPAP) SYTEM DRIVER	Nov 17, 2005	Substantially Equivalent	Cardinal Health
K051583	TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050	Nov 04, 2005	Substantially Equivalent	TIARA MEDICAL SYSTEMS, INC.
K052227	RESPCARE FACE MASK	Oct 28, 2005	Substantially Equivalent	RESPCARE INC.
K052110	M-SERIES PRO CPAP SYTEM	Oct 20, 2005	Substantially Equivalent	RESPIRONICS, INC.
K050994	AIRLIFE INFANT NASAL CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	Aug 03, 2005	Substantially Equivalent	Cardinal Health
K051314	RES TRAXX DATA CENTER	Jul 15, 2005	Substantially Equivalent	RESMED LTD.
K051559	IMASK, MODELS 100, 200 AND 300	Jul 08, 2005	Substantially Equivalent	VITAL SIGNS COLORADO, INC.
K050759	BIPAP AUTO	Jun 15, 2005	Substantially Equivalent	RESPIRONICS, INC.
K050072	GOODKNIGHT 425ST	Jun 13, 2005	Substantially Equivalent	NELLCOR PURITAN BENNETT, INC.
K050904	CPAP HUMIDIFIER, MODEL HC238JHU	May 25, 2005	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K050775	RESSCAN	May 10, 2005	Substantially Equivalent	RESMED LTD.
K041823	PIONEER U121 SERIES CPAP	May 10, 2005	Substantially Equivalent	MERITS HEALTH PRODUCTS CO., LTD.
K050171	IT NASAL MASK	May 04, 2005	Substantially Equivalent	INNOMED TECHNOLOGIES
K050359	ULTRA MIRAGE II MASK	Mar 16, 2005	Substantially Equivalent	RESMED LTD.
K042945	AURA CPAP SYSTEM	Mar 09, 2005	Substantially Equivalent	AEIOMED INC.
K040202	SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM	Mar 04, 2005	Substantially Equivalent	SALTER LABS
K050142	RESMED MERIDIAN MASK	Mar 01, 2005	Substantially Equivalent	RESMED LTD.
K043282	DEVILBISS AUTOADJUST, MODEL 9054 SERIES	Feb 11, 2005	Substantially Equivalent	SUNRISE MEDICAL
K043607	BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX	Jan 28, 2005	Substantially Equivalent	RESPIRONICS, INC.
K043382	TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840	Jan 19, 2005	Substantially Equivalent	TIARA MEDICAL SYSTEMS, INC.
K042455	DEVILBISS NASAL CPAP MASK, 9354 SERIES	Jan 14, 2005	Substantially Equivalent	SUNRISE MEDICAL
K042403	MIRAGE SWIFT	Oct 08, 2004	Substantially Equivalent	RESMED LTD.
K042294	SLUMBERGEAR(TM), MODEL MULTIPLE (004, 005, 005, 007)	Sep 10, 2004	Substantially Equivalent	SUITER ENTERPRISES, INC.
K042130	AURA CPAP PATIENT INTERFACE	Sep 08, 2004	Substantially Equivalent	AEIOMED INC.
K041900	HC604 CPAP HUMIDIFIER	Aug 31, 2004	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K041828	APEX MEDICAL CPAP MODEL 9S-003	Jul 30, 2004	Substantially Equivalent	APEX MEDICAL CORP.
K041819	GOODKNIGHT 425, MODELM-114500-00	Jul 22, 2004	Substantially Equivalent	MALLINCKRODT DEVELOPPEMENT FRANCE
K041362	RESMED HOSPITAL FULL FACE MASK	Jul 15, 2004	Substantially Equivalent	RESMED LTD.
K041209	RESMED S8 PIONEER CPAP SYSTEM	Jul 01, 2004	Substantially Equivalent	RESMED LTD.
K041309	IMASK TM	Jun 30, 2004	Substantially Equivalent	VITAL SIGNS, INC.
K040862	GUARDIAN NEONATE CPAP/HUMIDIFICATION SYSTEM	Jun 30, 2004	Substantially Equivalent	CARADYNE, LTD.
K034053	TMS SNAPP SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030 & TMS-3040	Jun 24, 2004	Substantially Equivalent	TIARA MEDICAL SYSTEMS, INC.
K040941	CPAP HUMIDIFIER, MODEL HC234 (AND RELATED ACCESSORIES)	Jun 10, 2004	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K041035	HOFFRICHTER TREND 110 CPAP DEVICE WITH AQUATREND III CPAP HUMIDIFIER ACCESSORY FOR TREND	Jun 09, 2004	Substantially Equivalent	HOFFRICHTER GMBH
K040944	RESCONTROL II	Jun 03, 2004	Substantially Equivalent	RESMED LTD.
K040726	VENTLAB NASAL CPAP CANNULA	Jun 03, 2004	Substantially Equivalent	VENTLAB CORP.
K041010	REMSTAR AUTO WITH C-FLEX CPAP SYSTEM	May 05, 2004	Substantially Equivalent	RESPIRONICS, INC.
K040506	FLEXIFIL SERIES HC431 FULL FACE MASK, MODEL HC431A	May 05, 2004	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K034033	RESCAN	May 05, 2004	Substantially Equivalent	RESMED LTD.
K033914	OXYGEN DIVERTER VALVE	Apr 22, 2004	Substantially Equivalent	RESMED LTD.
K040566	RESMED HOSPITAL NASAL MASK	Apr 02, 2004	Substantially Equivalent	RESMED LTD.
K031064	INVACARE POLARIS EX CPAP, MODEL ISP3000	Mar 12, 2004	Substantially Equivalent	INVACARE CORP.
K033841	RESMED S8 PRIME CPAP SYSTEM	Mar 10, 2004	Substantially Equivalent	RESMED LTD.
K030797	S7 ELITE CPAP SYSTEM WITH SOMNOTRAXX SYSTEM; AUTOSET SPIRIT CPAP SYSTEM WITH SOMNOTRAXX SYSTEM	Mar 10, 2004	Substantially Equivalent	RESMED CORP.
K032834	BIPAP PRO 2 BI-LEVEL SYSTEM	Mar 04, 2004	Substantially Equivalent	RESPIRONICS, INC.
K031935	TIARA MEDICAL SYSTEMS ADVANTAGE II NASAL MASK, MODELS TMS-2520 AND TMS-2530	Mar 03, 2004	Substantially Equivalent	TIARA MEDICAL SYSTEMS, INC.
K032056	BILEVEL CPAP, MODEL 9055 SERIES	Feb 20, 2004	Substantially Equivalent	SUNRISE MEDICAL
K033759	C2 NASAL MASK	Feb 19, 2004	Substantially Equivalent	RESPIRONICS, INC.
K031745	INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION	Feb 13, 2004	Substantially Equivalent	SENSORMEDICS CORP.
K022650	APEX MEDICAL CPAP RT 21XX	Feb 04, 2004	Substantially Equivalent	APEX MEDICAL CORP.
K033087	ORACLE ORAL MASK, MODEL HC451A	Jan 14, 2004	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K032916	MIRAGE ACTIVA MASK	Dec 04, 2003	Substantially Equivalent	RESMED LTD.
K023683	MULTI-STRAP FULL FACE MASK	Dec 01, 2003	Substantially Equivalent	ENGINEERED MEDICAL SYSTEMS
K032433	NASAL JACKS MASK	Oct 24, 2003	Substantially Equivalent	RESMED LTD.
K032480	AUTOSET SPIRIT SYSTEM	Oct 16, 2003	Substantially Equivalent	RESMED LTD.
K030985	BREAS PV 10I CPAP SYSTEM, MODEL PV 10I	Oct 15, 2003	Substantially Equivalent	VITAL SIGNS, INC.
K030563	ARABELLA NCPAP MASKS	Sep 09, 2003	Substantially Equivalent	HAMILTON MEDICAL AG
K031883	LYRA NASAL MASK	Aug 25, 2003	Substantially Equivalent	SENSORMEDICS CORP.
K031047	MIRAGE VISTA MASK	Aug 19, 2003	Substantially Equivalent	RESMED LTD.
K030843	VPAP III	Aug 15, 2003	Substantially Equivalent	RESMED LTD.
K014074	HOFFRICHTER VECTOR, VECTOR PLUS, VECTOR BI-VEVEL, VECTOR BI-LEVEL PLUS, SCALAR, SCALAR PLUS; CPAP WITH HUMIDIFIER OPTION	Jul 23, 2003	Substantially Equivalent	HOFFRICHTER GMBH
K024191	S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK	Jul 02, 2003	Substantially Equivalent	RESMED LTD.
K031460	MODIFICATION TO REMSTAR AUTO CPAP SYSTEM	Jun 24, 2003	Substantially Equivalent	RESPIRONICS, INC.
K023670	SINGLE USE ORAL MASK, MODEL HC455A	Jun 12, 2003	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K023559	FISHER & PAYKEL HEALTHECARE ORACLE ORAL MASK	Jun 12, 2003	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K031470	PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US	Jun 05, 2003	Substantially Equivalent	TYCO HEALTHCARE NANCY
K030822	7600 SERIES MULTI-PATIENT MULTI-USE ORO-NASAL CPAP/NPPV MASKS	Jun 03, 2003	Substantially Equivalent	HANS RUDOLPH, INC.
K023068	PAPILLON MASK SET	May 28, 2003	Substantially Equivalent	MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH
K030798	MIRAGE ACTIVA MASK	Apr 09, 2003	Substantially Equivalent	RESMED LTD.
K022642	TWLIGHT, MODEL ISP 9600	Feb 11, 2003	Substantially Equivalent	INVACARE CORP.
K022192	PEGASUS NASAL CPAP SYSTEM	Jan 24, 2003	Substantially Equivalent	SENSORMEDICS CORP.
K023306	MIRAGE FULL FACE MASK SERIES 2	Nov 27, 2002	Substantially Equivalent	RESMED LTD.
K023284	MIRAGE FULL FACE MASK SERIES 2	Nov 27, 2002	Substantially Equivalent	RESMED LTD.
K023244	MIRAGE FULL FACE MASK SERIES 2	Nov 27, 2002	Substantially Equivalent	RESMED LTD.
K022934	SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650	Nov 14, 2002	Substantially Equivalent	GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS
K020886	PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US	Nov 01, 2002	Substantially Equivalent	TYCO HEALTHCARE NANCY
K020641	SPIRITUS(TM) RESPIRATORY SYSTEM #SRS 001	Oct 29, 2002	Substantially Equivalent	WORLDWIDE MEDICAL TECHNOLOGIES, LLC
K020759	7600 SERIES REUSABLE FULL-FACE CPAP/NIPPV MASKS MODELS 7620 LARGE, 7630 MEDIUM, 7640 SMALL, 7650 EXTRA SMALL, 7660 PETIT	Aug 13, 2002	Substantially Equivalent	HANS RUDOLPH, INC.
K013843	AUTOSET SPIRIT CPAP SYSTEM	Jul 16, 2002	Substantially Equivalent	RESMED CORP.
K013909	S7 ELITE CP AP SYSTEM	Jul 08, 2002	Substantially Equivalent	RESMED CORP.
K021534	IQ NASAL MASK, MODEL 50160 REV. D	Jul 02, 2002	Substantially Equivalent	SLEEPNET CORPORATION
K021861	REMSTAR PRO WITH C-FLEX CPAP SYSTEM	Jun 19, 2002	Substantially Equivalent	RESPIRONICS, INC.
K020730	ORION NASAL CPAP SYSTEM	May 22, 2002	Substantially Equivalent	BIRD PRODUCTS CORP.
K012554	REMSTAR AUTO CPAP SYSTEM	Jan 29, 2002	Substantially Equivalent	RESPIRONICS, INC.
K013738	WEINMANN SOMNOMASK	Jan 22, 2002	Substantially Equivalent	GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS
K013421	LIFEGUARD NASAL CPAP MASK AND ACCESSORIES	Jan 08, 2002	Substantially Equivalent	LIFEGUARD MEDICAL PRODUCTS, INC.
K013306	MINIME NASAL MASK, MODEL P/N 50220	Nov 02, 2001	Substantially Equivalent	SLEEPNET CORPORATION
K012034	MODIFICATION TO: SIPAP INFANT NASAL CPAP CIRCUIT	Jul 24, 2001	Substantially Equivalent	SENSORMEDICS CORP.
K012207	ADVANTAGE NASAL MASK, SMALL, ADVANTAGE NASAL MASK. REGULAR, MODELS TMS-2520, TMS 2530	Jul 23, 2001	Substantially Equivalent	TIARA MEDICAL SYSTEMS, INC.
K011229	DEVILBISS 9000 SERIES CPAP, MODEL 9001	Jul 11, 2001	Substantially Equivalent	SUNRISE MEDICAL HHG, INC.
K011714	BIPAP PRO BI-LEVEL SYSTEM	Jun 28, 2001	Substantially Equivalent	RESPIRONICS, INC.
K003894	ORACLE ORAL MASK	Jun 25, 2001	Substantially Equivalent	FISHER & PAYKEL HEALTHCARE, LTD.
K011516	INFANT FLOW SYSTEM, MODEL M672P	Jun 08, 2001	Substantially Equivalent	EME (ELECTRO MEDICAL EQUIPMENT) LTD.
K002763	REMREST	May 04, 2001	Substantially Equivalent	MEDICAL INDUSTRIES AMERICA, INC.
K010704	DORNIR LC-1 CPAP SYSTEM	Apr 18, 2001	Substantially Equivalent	PRYM MEDICAL LTD.
K010263	REMSTAR PLUS CPAP SYSTEM	Mar 29, 2001	Substantially Equivalent	RESPIRONICS, INC.
K993094	AERO-CLICK	Oct 23, 2000	Substantially Equivalent	MAP MEDIZINTECHNIK FUR ARZT UND PATIENT GMBH
K002465	SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876	Sep 08, 2000	Substantially Equivalent	RESPIRONICS, INC.
K000705	RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223	Sep 08, 2000	Substantially Equivalent	RESPIRONICS, INC.
K002001	BREEZE SLEEPGEAR WITH DREAMSEAL	Sep 06, 2000	Substantially Equivalent	PURITAN BENNETT CORP.
K000888	SANSIBAR CPAP SYSTEM	Aug 15, 2000	Substantially Equivalent	PRYM MEDICAL LTD.
K001553	BREAS PV 100 CPAP SYSTEM	Aug 03, 2000	Substantially Equivalent	VITAL SIGNS, INC.
K001845	MALLINCKRODT, GOODKNIGHT 418S	Jul 05, 2000	Substantially Equivalent	MALLINCKRODT DEVELOPPEMENT FRANCE
K000994	BIPAP DUET LX BI-LEVEL SYSTEM	Jun 22, 2000	Substantially Equivalent	RESPIRONICS, INC.
K000215	SWIVEL ELBOW	May 26, 2000	Substantially Equivalent	ENGINEERED MEDICAL SYSTEMS
K992192	AIRPILOTMASK, MODEL TMS-900	May 12, 2000	Substantially Equivalent	TIARA MEDICAL SYSTEMS, INC.
K993584	MALLINCKRODT, GOODKNIGHT 418A, GOODKNIGHT 418P, SILVERLINING 2	Mar 07, 2000	Substantially Equivalent	NELLCOR PURITAN BENNETT FRANCE DVPT.
K990856	HERITAGE NASAL CPAP SYSTEM, MODEL P/N 15682	Jan 11, 2000	Substantially Equivalent	BIRD PRODUCTS CORP.
K992384	CPAP/PRO CPAP INTERFACE	Dec 01, 1999	Substantially Equivalent	STEVENSON INDUSTRIES, INC.
K990659	NASAL AIRE	Nov 26, 1999	Substantially Equivalent	BREATHING TECHNOLOGIES CORP.
K992969	RESPIRONICS TOTAL FACE MASK	Nov 10, 1999	Substantially Equivalent	RESPIRONICS, INC.
K993433	VIRTUOSO LX SMART CPAP SYSTEM	Oct 27, 1999	Substantially Equivalent	RESPIRONICS, INC.
K993307	ARIA LX CPAP SYSTEM	Oct 27, 1999	Substantially Equivalent	RESPIRONICS, INC.
K993269	IQ NASAL MASK, MODEL P/N 50160	Oct 27, 1999	Substantially Equivalent	SLEEPNET CORPORATION
K991926	OPAP	Oct 18, 1999	Substantially Equivalent	OPAP, INC.
K992336	MONARCH II MINI MASK	Aug 13, 1999	Substantially Equivalent	RESPIRONICS, INC.
K991972	INFANT FLOW SYSTEM	Aug 13, 1999	Substantially Equivalent	SENSORMEDICS CORP.
K984428	SULLIVAN AUTOSET NASAL CPAP SYSTEM	Jul 26, 1999	Substantially Equivalent	RESMED LTD.
K991648	REUSABLE CONTOUR II NASAL MASK	May 28, 1999	Substantially Equivalent	RESPIRONICS, INC.
K991150	NELLCOR PURITAN BENNETT, GOODKNIGHT 418G	Apr 14, 1999	Substantially Equivalent	NELLCOR PURITAN BENNETT FRANCE DVPT.
K984254	INFANT FLOW NCPAP MASKS	Feb 24, 1999	Substantially Equivalent	SENSORMEDICS CORP.
K982242	INVACARE CPAP	Jan 27, 1999	Substantially Equivalent	INVACARE CORP.
K980551	SILENZIO DELTA CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	Nov 17, 1998	Substantially Equivalent	NIDEK MEDICAL PRODUCTS, INC.
K982530	SULLIVAN MIRAGE FULL FACE MASK	Oct 16, 1998	Substantially Equivalent	RESMED LTD.
K981744	COMBINATION TOA WITH NASAL MASK HOLDER AND UNIVERSAL NASAL MASK HOLDER	Oct 14, 1998	Substantially Equivalent	W. KEITH THORNTON, D.D.S.
K980721	SULLIVAN AUTOSET	Sep 01, 1998	Substantially Equivalent	RESMED LTD.
K974453	NASAL INTERFACE MODEL 7910	Aug 04, 1998	Substantially Equivalent	HEALTHDYNE TECHNOLOGIES, INC.
K980365	GOODKNIGHT 418 CPAP SYSTEM	Jul 22, 1998	Substantially Equivalent	NELLCOR PURITAN BENNETT, INC.
K973161	CPAP HUMIDIFIER (HC 200)	Jul 10, 1998	Substantially Equivalent	FISHER & PAYKEL ELECTRONICS LTD.
K974879	MODEL 7410 VOYAGER	Jun 29, 1998	Substantially Equivalent	HEALTHDYNE TECHNOLOGIES, INC.
K974303	INFANT FLOW SYSTEM	Jan 30, 1998	Substantially Equivalent	SENSORMEDICS CORP.
K972605	EMS NASAL CPAP MASK	Jan 28, 1998	Substantially Equivalent	ENGINEERED MEDICAL SYSTEMS
K964092	TMS COMFORT SERIES NASAL CPAP MASK	Jul 31, 1997	Substantially Equivalent	TIARA MEDICAL SYSTEMS, INC.
K970771	SULLIVAN AUTOSET PORTABLE II NASAL CPAP SYSTEM	Jun 20, 1997	Substantially Equivalent	RESMED LTD.
K964019	MORPHEE PLUS ALPHA	Jun 18, 1997	Substantially Equivalent	NELLCOR PURITAN BENNETT, INC.
K970516	SULLIVAN AUTOSET HOME NASAL CPAP SYSTEM	May 09, 1997	Substantially Equivalent	RESMED LTD.
K963761	QUARTET CLINICAL SYSTEM	Apr 18, 1997	Substantially Equivalent	RESPIRONICS, INC.
K970173	MODEL 1700 TRANQUILITY BILEVEL SYSTEM	Apr 16, 1997	Substantially Equivalent	HEALTHDYNE TECHNOLOGIES, INC.
K951944	NASALFLAIR	Mar 28, 1997	Substantially Equivalent	AIRWAYS LTD., INC.
K964363	BIPAP DUET SYSTEM	Jan 30, 1997	Substantially Equivalent	RESPIRONICS, INC.
K962203	WHISPER SWIVEL II EXHALATION PORT	Dec 05, 1996	Substantially Equivalent	RESPIRONICS, INC.
K963250	PRESSURE VALVE	Nov 14, 1996	Substantially Equivalent	RESPIRONICS, INC.
K962713	DPAP STEALTH SLEEPNET MODEL NUMBER 84000	Oct 23, 1996	Substantially Equivalent	SLEEPNET CORPORATION
K953930	VIRTUOSO SMART CPAP SYSTEM	Sep 30, 1996	Substantially Equivalent	RESPIRONICS, INC.
K961915	SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE	Aug 15, 1996	Substantially Equivalent	RESPIRONICS, INC.
K961783	SULLIVAN VPAP II ST NASAL VPAP SYSTEM	Aug 01, 1996	Substantially Equivalent	RESMED LTD.
K943207	NITELIFE BI-LEVEL CPAP	Jul 29, 1996	Substantially Equivalent	AIRSEP CORP.
K961626	SOLO CPAP SYSTEM	Jul 18, 1996	Substantially Equivalent	RESPIRONICS, INC.
K952429	RES CARE AUTO SET CLINICAL, PORTABLE SYSTEM, PORTABLE 2 SYSTEM	Jul 02, 1996	Substantially Equivalent	RESCARE LTD.
K954572	MAESTRO CLINICAL REMOTE CONTROL	Jun 26, 1996	Substantially Equivalent	RESPIRONICS, INC.
K953697	THE IMS DPAP MASK, IMS MODEL NUMBER 82000	Jun 13, 1996	Substantially Equivalent	SLEEPNET CORPORATION
K952475	SULLIVAN NOSE & MOUTH MASK SYSTEM	May 28, 1996	Substantially Equivalent	RESCARE LTD.
K960518	THE PURITAN-BENNETT 318 PLUS NASAL CPAP SYSTEM	May 09, 1996	Substantially Equivalent	PURITAN BENNETT CORP.
K952966	CP-90 CONTINUOUS POSITIVE AIRWAY PRESSURE SYSTEM	May 07, 1996	Substantially Equivalent	NIDEK MEDICAL PRODUCTS, INC.
K950849	MODEL #7354	Feb 08, 1996	Substantially Equivalent	DEVILBISS HEALTH CARE, INC.
K954207	GEL MASK	Jan 31, 1996	Substantially Equivalent	RESPIRONICS, INC.
K952491	MODEL 7355	Jan 31, 1996	Substantially Equivalent	DEVILBISS HEALTH CARE, INC.
K945938	RESPIRONICS MONARCH MINI MASK	Jan 31, 1996	Substantially Equivalent	RESPIRONICS, INC.
K953341	ARIA CPAP SYSTEM	Jan 30, 1996	Substantially Equivalent	RESPIRONICS, INC.
K952292	PURITAN-BENNETT COMPANION NASAL CPAP SYSTEM	Nov 13, 1995	Substantially Equivalent	PURITAN BENNETT CORP.
K950331	PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)	Sep 21, 1995	Substantially Equivalent	HEALTHDYNE, INC.
K936047	SPECTRUM(TM) MASK	Mar 29, 1995	Substantially Equivalent	RESPIRONICS, INC.
K934804	PURITAN-BENNETT COMPANION 320 I/E	Feb 27, 1995	Substantially Equivalent	PURITAN BENNETT CORP.
K933184	POSITIVE AIRWAY PRESSURE SYSTEM	Nov 28, 1994	Substantially Equivalent	INNOVATIVE MEDICAL SYSTEMS, INC.
K935979	CONTINUOUS POSITIVE AIRWAY PRESSURE CPAP SYSTEM	Nov 10, 1994	Substantially Equivalent	DEVILBISS HEALTH CARE, INC.
K933947	LIFECARE CPAP-200	Nov 10, 1994	Substantially Equivalent	LIFECARE INTERNATIONAL,INC.
K943509	7300 NASAL CPAP SYSTEM	Aug 05, 1994	Substantially Equivalent	HEALTHDYNE TECHNOLOGIES, INC.
K935784	PURITAN-BENNETT COMPANION 320 I/E BI-LEVEL RESPIRATORY SYSTEM	Jul 13, 1994	Substantially Equivalent	PURITAN-BENNETT
K931884	SULLIVAN NASAL VPAP SYSTEM	Jun 07, 1994	Substantially Equivalent	RESCARE LTD.
K930656	SULLIVAN III NASAL CPAP SYSTEM	Mar 15, 1994	Substantially Equivalent	RESCARE LTD.
K931484	REPLACEMENT BATTER FOR ABBOTT LABS LIFECARE 4100 S	Feb 17, 1994	Substantially Equivalent	PORTABLE POWER SYSTEMS, INC.
K925587	NASAL/ORAL MASK	Sep 14, 1993	Substantially Equivalent	RESPIRONICS, INC.
K925920	TOTAL FACE MASK	Jul 21, 1993	Substantially Equivalent	RESPIRONICS, INC.
K923590	318A RESPIRATORY SUPPORT SYSTEM	Apr 09, 1993	Substantially Equivalent	PURITAN BENNETT CORP.
K920699	REMSTAR WTIH RAMP AND REMOTE MODIFICATION	Dec 07, 1992	Substantially Equivalent	RESPIRONICS, INC.
K911465	INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL	Oct 18, 1991	Substantially Equivalent	VITAL SIGNS, INC.
K912224	LIFECARE CPAP-100	Sep 23, 1991	Substantially Equivalent	LIFECARE SERVICES, INC.
K911856	RESPIRONICS REMSTAR WITH REMOTE AND RAMP	Aug 09, 1991	Substantially Equivalent	RESPIRONICS, INC.
K912434	SALTER LABS INFANT NASAL CPAP CANNULA	Jul 30, 1991	Substantially Equivalent	SALTER LABS
K911780	INFANT NASAL CANNULAE ASSEMBLY, MODIFIED	Jun 24, 1991	Substantially Equivalent	ACKRAD LABORATORIES
K910194	COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM	May 13, 1991	Substantially Equivalent	PURITAN BENNETT CORP.
K905404	MEDTRONIC SULLIVAN NASAL CPAP SYSTEM	May 13, 1991	Substantially Equivalent	MEDTRONIC VASCULAR
K904344	SLEEPER MASK SYSTEM	May 01, 1991	Substantially Equivalent	DEVILBISS HEALTH CARE, INC.
K905593	SLEEPAP	Apr 23, 1991	Substantially Equivalent	MEDICAL INDUSTRIES AMERICA, INC.
K904766	DEVILBISS MODEL 7352 SERIES	Mar 26, 1991	Substantially Equivalent	DEVILBISS HEALTH CARE, INC.
K905540	RESPIRONICS BIPAP REMOTE CONTROL UNIT	Jan 30, 1991	Substantially Equivalent	RESPIRONICS, INC.
K895031	MODIFIED INFANT NASAL CANNULAE ASSEMBLY	Oct 30, 1989	Substantially Equivalent	ACKRAD LABORATORIES
K871351	H-H HARRIS NEONATAL NASAL CANNULA SET FOR CPAP	May 14, 1987	Substantially Equivalent	HOLTER-HAUSNER INTL.
K871157	C.P.A.P. NASAL CANNULA	Apr 21, 1987	Substantially Equivalent	HUDSON OXYGEN THERAPY SALES CO.
K864883	NEONATAL CANNULA CAP	Jan 28, 1987	Substantially Equivalent	BEHAN & TAYLOR ENT.
K863746	BIRD NIGHTBIRD NASAL CPAP SYSTEM	Dec 15, 1986	Substantially Equivalent	BIRD PRODUCTS CORP.
K862448	FLOW GENERATOR FOR SLEEP APNEA, LDS 1500	Nov 14, 1986	Substantially Equivalent	LIFE DESIGN SYSTEMS, INC.
K861555	CIRCAPAK UNIVERSAL VOLUME VENTILATOR CIRCUIT	Jun 05, 1986	Substantially Equivalent	RESPIRATORY CARE, INC.
K861280	MEDICOMP CPAP NASAL CANNULA	May 09, 1986	Substantially Equivalent	MEDICOMP, INC.
K853487	PATIENT BREATHING CIRCUIT	Sep 06, 1985	Substantially Equivalent	INFRASONICS CORP.
K852821	DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)	Jul 29, 1985	Substantially Equivalent	PURITAN BENNETT CORP.
K841773	INFANT NASAL CANNULAE ASSEMBLY	Jul 26, 1984	Substantially Equivalent	ACKRAD LABORATORIES
K823936	CPAP INFANT NASAL CANNULAE SET	Jan 28, 1983	Substantially Equivalent	ACKRAD LABORATORIES
K813075	TRITEC DOC TM	Dec 09, 1981	Substantially Equivalent	TRI-TECH, INC.
K811409	ARGYLE CPAP NASAL CANNULA	Jun 02, 1981	Substantially Equivalent	SHERWOOD MEDICAL CO.
K792722	NOVAMETRIX CPAP NASAL CANNULA	Jan 24, 1980	Substantially Equivalent	NOVAMETRIX MEDICAL SYSTEMS, INC.
K771217	ANESTHESIA RESPIRATOR	Aug 04, 1977	Substantially Equivalent	RULE MEDICAL INSTRUMENTS, INC.

FEI Numbers

This FDA classification entry is associated with 109 FEI numbers. Click on an entry to view related FDA registrations.

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1000137514: 24 registrations

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1222088: 19 registrations

1314417: 210 registrations

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1832562: 23 registrations

1922553: 6 registrations

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2000044808: 4 registrations

2011171: 834 registrations

2024500: 35 registrations

2246552: 325 registrations

2518422: 147 registrations

3000126629: 658 registrations

3000143502: 23 registrations

3000210616: 107 registrations

3001084824: 32 registrations

3001104093: 90 registrations

3001319476: 53 registrations

3001400310: 11 registrations

3002797442: 37 registrations

3002806988: 107 registrations

3002807391: 147 registrations

3002807626: 58 registrations

3002973578: 29 registrations

3003001596: 44 registrations

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3003319165: 44 registrations

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3004604967: 87 registrations

3004672275: 8 registrations

3004727093: 79 registrations

3004748541: 25 registrations

3004802249: 7 registrations

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3006157842: 56 registrations

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3006446479: 39 registrations

3006783791: 51 registrations

3007009701: 4 registrations

3007135420: 19 registrations

3007220521: 10 registrations

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3020283264: 23 registrations

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3025360937: 4 registrations

3026086583: 12 registrations

3026400132: 1 registration

3027344650: 5 registrations

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3029706818: 48 registrations

3030970580: 15 registrations

3031369651: 31 registrations

3031869923: 1 registration

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3033530343: 11 registrations

3038131744: 1 registration