Product Code: CCQ FDA class 1 21 CFR 868.5640

Nebulizer, Medicinal, Non-Ventilatory (Atomizer)

Anesthesiology

The Non-Ventilatory Medicinal Nebulizer (Atomizer) is an anesthesiology device that generates a fine aerosol mist from liquid medications for inhalation by spontaneously breathing patients, not intended for use in-line with mechanical ventilation circuits. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CCQ, regulated under 21 CFR 868.5640, within the Anesthesiology medical specialty. No special flags apply to this device.

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510(k)s

FEI Numbers

140

Registration Numbers

140

Unique Applicants

Years Active

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Basic Information

Product Code: CCQ
Device Class: FDA class 1
Regulation Number: 868.5640
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 62 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972397	EZ SPRAY	Sep 23, 1997	Substantially Equivalent	Intertex Research, Inc.
K964956	E-Z SPACER MASK (SMALL)	Apr 23, 1997	Substantially Equivalent	Airpharma, LLC
K961894	MDI TUTOR	Aug 14, 1996	Substantially Equivalent	Mdi Tutor, Inc.
K961455	MEDSHIELD/AEROCHAMBER	Jul 25, 1996	Substantially Equivalent	Diemolding Corp.
K960593	SMARTMIST ASTHMA MANAGMENT SYSTEM, SMARTMIST, MODEL NUMBER SM-100/SMARTMIST SPIROMETRY AIRWAY, MODEL NUMBER SA-100	May 10, 1996	Substantially Equivalent	Aradigm Corp.
K922033	SALINE SOLUTION- STERILE	Jul 21, 1992	Substantially Equivalent	Trinity Laboratories, Inc.
K900576	MODIFIED AEROCHAMBER WITH MASK	May 13, 1991	Substantially Equivalent	Monaghan Medical Corp.
K900557	MODIFIED AEROCHAMBER M.V. AEROSOL HOLDING CHAMBER	Apr 10, 1991	Substantially Equivalent	Monaghan Medical Corp.
K895115	FRANK INHALER THERMAL S	May 18, 1990	Substantially Equivalent	Buttner-Frank GmbH
K894215	EVOLUTION ULTRASONIC	Apr 16, 1990	Substantially Equivalent	Medical Industries America, Inc.
K894555	PARI INHALIERBOY TYPE 37.80 DOUBLE INSULATED	Jan 24, 1990	Substantially Equivalent	Dura Pharmaceuticals, Inc.
K896070	PFEIFFER METERED DOSAGE SYSTEM	Jan 17, 1990	Substantially Equivalent	Syva Co.
K895592	FREEWAY NEBULIZER COMPRESSOR	Nov 21, 1989	Substantially Equivalent	Lifecare Services, Inc.
K894441	DEVILBISS MODEL 6610D	Oct 13, 1989	Substantially Equivalent	Devilbiss Health Care, Inc.
K894244	DEVILBISS MODEL 8500D AND 8500D-608	Oct 06, 1989	Substantially Equivalent	Devilbiss Health Care, Inc.
K892117	GENTLEHALER(R)	Jun 23, 1989	Substantially Equivalent	Schering Research
K875024	DEY-PAK AND DEY-VIAL SODIUM CHLORIDE SOLUTION, USP	Jan 22, 1988	Substantially Equivalent	Dey Laboratories, Inc.
K875011	DEY-PAK PURIFIED WATER, USP, STERILE	Jan 22, 1988	Substantially Equivalent	Dey Laboratories, Inc.
K874513	MONAGHAN AEROCHAMBER WITH MASK	Dec 30, 1987	Substantially Equivalent	Monaghan Medical Corp.
K873793	INSPIREASE(R), DRUG DELIVERY SYSTEM	Oct 13, 1987	Substantially Equivalent	Key Pharmaceuticals, Inc.
K873477	INTERMITTENT SIGNAL ACTUATED NEBULIZER (VISAN)	Oct 09, 1987	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K872315	MISTMASTER	Sep 11, 1987	Substantially Equivalent	Sonora Respiratory Products, Inc.
K871151	THE SPIRA ELEKTRO 2	May 15, 1987	Substantially Equivalent	Warren E. Collins, Inc.
K870332	PREFILLED RESPIRATORY THERAPY VIALS	Apr 01, 1987	Substantially Equivalent	Automatic Liquid Packaging, Inc.
K870755	CHALLENGER DOSIMETER	Mar 16, 1987	Substantially Equivalent	Salter Labs
K870027	HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER	Mar 16, 1987	Substantially Equivalent	Salter Labs
K860800	ROSENTHAL-FRENCH NEBULIZATION DOSIMETER	Mar 27, 1986	Substantially Equivalent	Laboratory For Applied Immunology, Inc.
K860875	CIRRUS DRUG NEBULIZER MK III	Mar 20, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K854952	CIRRUS NEBULIZER-DELUXE KIT	Jan 28, 1986	Substantially Equivalent	Dhd Medical Products Div. Diemolding Corp.
K854551	MEDIPART RADIOAEROSOL DELIVERY SYS FOR ULTRAVENT S	Dec 19, 1985	Substantially Equivalent	Medipart Jerry Alexander
K854550	MEDIPART REMOTE INJECTION SYS FOR ULTRAVENT RADIOA	Dec 19, 1985	Substantially Equivalent	Medipart Jerry Alexander
K854520	PULMO-AIDE MODEL 5610D	Dec 09, 1985	Substantially Equivalent	The Devilbiss Co.
K852627	MAXI-NEB	Sep 26, 1985	Substantially Equivalent	Ashai Co. , Ltd.
K853350	SYNCHRONER TM (PROPOSED TRADENAME)	Aug 29, 1985	Substantially Equivalent	Fisons Corp.
K853071	MEDIX ELECTRONIC NEBULIZING SYSTEM	Aug 29, 1985	Substantially Equivalent	Medix Corp.
K851525	PFEIFFER PUMP	Aug 08, 1985	Substantially Equivalent	Ing. Erich Pfeiffer GmbH & Co. Kg.
K851254	MICRO-INHALER MODEL TV-7000 & TV-8000	Jun 18, 1985	Substantially Equivalent	Bioclimatic, Inc.
K850926	MICRON ONE PORTA. ULTRASONIC NEBULIZER	May 23, 1985	Substantially Equivalent	Endotek Development Laboratories
K844591	MIST-EASE NEBULIZER	Dec 13, 1984	Substantially Equivalent	General Physiotherapy, Inc.
K843102	AVA-NEB NEBULIZER	Aug 17, 1984	Substantially Equivalent	Avatron, Inc.
K842988	VMT GENTLE-HALER	Aug 07, 1984	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K841991	ARM-A-CARE HUMIDIFIER-RESPIRATORY GAS	Jul 27, 1984	Substantially Equivalent	Armour Pharmaceutical Co.
K841990	ARM-A-CARE NEBULIZER-NEBULIZER	Jul 27, 1984	Substantially Equivalent	Armour Pharmaceutical Co.
K841989	ARM-A-VIAL LV SODIUM CHLORIDE INHALAT	Jul 27, 1984	Substantially Equivalent	Armour Pharmaceutical Co.
K841988	ARM-A-VIAL LV SODIUM, CHLORIDE INHALAT	Jul 27, 1984	Substantially Equivalent	Armour Pharmaceutical Co.
K841987	ARM-A-VIAL LV STERIAL WATER FOR INHALA	Jul 27, 1984	Substantially Equivalent	Armour Pharmaceutical Co.
K842192	CROUP TENT FRAME	Jun 25, 1984	Substantially Equivalent	Home Run Treadmill Co.
K841894	VMT HAND HELD NEBULIZER	Jun 05, 1984	Substantially Equivalent	Vortran Medical Technology 1, Inc.
K841469	MISTY OX DISPOS. NEBULIZER	Apr 24, 1984	Substantially Equivalent	Medical Molding Corp. of America
K841321	AIR-NEB NEBULIZER COMPRESSOR UNIT	Apr 13, 1984	Substantially Equivalent	Airmed Corp.
K833474	VIRALIZER NEBULIZER SPRAYER	Dec 27, 1983	Substantially Equivalent	Viral Response System, Inc.
K832037	INSPIREASE	Aug 16, 1983	Substantially Equivalent	Key Pharmaceuticals, Inc.
K823423	NEBULIZER CHRONOLOG & INTERPRETER	Dec 15, 1982	Substantially Equivalent	Advanced Technology Products, Inc.
K822625	SYNTEVENT ATOMIZER/NEBULIZER AEROSOL	Oct 13, 1982	Substantially Equivalent	Syva Co.
K812503	BOSCH HEARING INSTRUMENTS	Sep 24, 1981	Substantially Equivalent	Retlif, Inc.
K811404	TRAVELAIRE	Jun 09, 1981	Substantially Equivalent	B & F Medical Products, Inc.
K810343	NEBULIZERS	Mar 17, 1981	Substantially Equivalent	Todd Industries, Inc.
K802281	SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC	Oct 03, 1980	Substantially Equivalent	Sherwood Medical Co.
K800763	MISER INHALATION DEVICE, PART NO. 700	Apr 24, 1980	Substantially Equivalent	Vix Breathing Equipment Co.
K781394	DISPOSABLE INCENTIVE SPIROMETER	Oct 16, 1978	Substantially Equivalent	Inhal-O-Tech Medical Plastic
K781073	PULMO-SONIC	Sep 27, 1978	Substantially Equivalent	The Devilbiss Co.
K760580	DRUG NEBULIZER	Sep 21, 1976	Substantially Equivalent	Ohio Medical Products