Product Code: BTI FDA class 2 21 CFR 868.6250

Compressor, Air, Portable

Anesthesiology

The Compressor, Air, Portable is a portable powered device that compresses ambient air for delivery to patients or medical equipment in clinical settings, commonly used to power pneumatically driven medical devices. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is BTI, regulated under 21 CFR 868.6250 in the Anesthesiology specialty.

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510(k)s

FEI Numbers

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Unique Applicants

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Basic Information

Product Code: BTI
Device Class: FDA class 2
Regulation Number: 868.6250
Medical Specialty: Anesthesiology
Review Panel: AN
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 74 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K131881	OMBRA TABLE TOP COMPRESSOR	Oct 24, 2013	Substantially Equivalent	Trudell Medical Intl.
K113338	MEDICAL AIR COMPRESSOR	Aug 10, 2012	Substantially Equivalent	Oricare, Inc.
K091871	DK50 DS	Oct 23, 2009	Substantially Equivalent	Ekom S.R.O.
K072634	EMG TRITON -COMP,MODEL NCA01-XXX SERIES	Nov 19, 2008	Substantially Equivalent	Emg Technology Co., Ltd.
K060781	MEDICAL COMPRESSOR, MODELS DK50 D AND DM	Oct 03, 2006	Substantially Equivalent	Ekom S.R.O.
K051691	MINIMATE COMPRESSOR	Dec 09, 2005	Substantially Equivalent	Precision Medical, Inc.
K041781	VENTILAIR II MEDICAL AIR COMPRESSOR	Mar 14, 2005	Substantially Equivalent	Hamilton Medical AG
K041406	NEWPORT C250 AIR COMPRESSOR MODEL C250	Dec 15, 2004	Substantially Equivalent	Newport Medical Instruments
K041974	MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER	Aug 24, 2004	Substantially Equivalent	Med2000 S.R.L.
K040220	MEDICAL AIR COMPRESSOR	Jun 09, 2004	Substantially Equivalent	eVent Medical, Ltd.
K031686	AEROMIST LT, MODEL HCS15004	Jan 21, 2004	Substantially Equivalent	Medline Industries, Inc.
K031413	VIGORMIST COMPRESSOR NEBULIZER	Oct 07, 2003	Substantially Equivalent	Vega Technologies, Inc.
K023354	COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E	Sep 05, 2003	Substantially Equivalent	Siemens Elema AB
K020797	PULMO-MIST COMPRESSOR MODEL # 4323	May 03, 2002	Substantially Equivalent	Nidek Medical Products, Inc.
K013027	MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123	Dec 06, 2001	Substantially Equivalent	Respironics Healthscan, Inc.
K002862	PRONEB ULTRA MODEL NUMBER 85B0100	Mar 13, 2001	Substantially Equivalent	Pari Holding Co.
K002468	SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050	Mar 02, 2001	Substantially Equivalent	San UP S.A.
K982789	MEDICAL AIR COMPRESSOR, MODEL # 8413419	Oct 29, 1998	Substantially Equivalent	Drager, Inc.
K963349	DEVILBISS 8650D	Jun 13, 1997	Substantially Equivalent	Devilbiss Health Care, Inc.
K951926	ALRECO 40400	Dec 08, 1995	Substantially Equivalent	Allan Rehnstrom AB
K945478	AM-50 AEROSOL/MEDICATION AIR COMPRESSOR	Sep 28, 1995	Substantially Equivalent	Preferred Medical Supply, Inc.
K952616	MICROTIME	Sep 27, 1995	Substantially Equivalent	Westmed Intl.
K946039	MODEL #5000 PULMO PLUS	Jun 16, 1995	Substantially Equivalent	International Medical Systems
K940630	503 MAXI COMPRESSOR	Feb 21, 1995	Substantially Equivalent	Medical Industries America, Inc.
K930509	PM PUMP COMPRESSOR	Oct 28, 1994	Substantially Equivalent	Precision Medical, Inc.
K925010	NEBULIZER PUMP, POWERED, MODEL 1110	May 27, 1994	Substantially Equivalent	Thomas Industries
K925011	NEBULIZER PUMP, POWERED MODEL 1180	Jan 12, 1994	Substantially Equivalent	Thomas Industries
K931015	DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER	Sep 30, 1993	Substantially Equivalent	Devilbiss Health Care, Inc.
K913097	SAM ST	Dec 11, 1992	Substantially Equivalent	Ferguson Medical
K922623	NEBULIZER SYSTEM	Dec 01, 1992	Substantially Equivalent	Healthdyne, Inc.
K920954	AIR STAR	Aug 03, 1992	Substantially Equivalent	Infrasonics Corp.
K902520	AIR PLUS NEBULIZER	Mar 04, 1991	Substantially Equivalent	Diamond Medical Equipment, Inc.
K904045	#504 MINI COMPRESSOR	Feb 12, 1991	Substantially Equivalent	Medical Industries America, Inc.
K902184	MAXI ASPIRATOR	Feb 12, 1991	Substantially Equivalent	Medical Industries America, Inc.
K902762	PM14 SOFT AIR COMPRESSOR	Jul 30, 1990	Substantially Equivalent	Precision Medical, Inc.
K900686	MAXI COMPRESSORS	Apr 26, 1990	Substantially Equivalent	Medical Industries America, Inc.
K894831	PORTABLE AIR COMPRESSOR MODEL NUMBER 8125	Oct 24, 1989	Substantially Equivalent	Equi-Tron Mfg., Inc.
K883829	TURBO AIR COMPRESSOR 8000	Mar 23, 1989	Substantially Equivalent	Necon Medical, Inc.
K884722	LUMINEB I	Feb 03, 1989	Substantially Equivalent	Lumiscope Co., Inc.
K883704	MULTIICHALLENGE NEBULIZER SYSTEM	Nov 28, 1988	Substantially Equivalent	Biotrine Corp.
K883132	NEBULIZER PUMP POWERED MODELS 020 AND 050	Oct 18, 1988	Substantially Equivalent	Travelneb, Inc.
K873677	ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER	Oct 20, 1987	Substantially Equivalent	Mountain Medical Equipment, Inc.
K871829	SIEMENS DRY AIR COMPRESSOR	Jun 15, 1987	Substantially Equivalent	Siemens Elema AB
K870428	AEROSOL ONE, NEBULIZER PUMP	May 15, 1987	Substantially Equivalent	Ashai Co. , Ltd.
K864547	BIRD 6500 AIR COMPRESSOR	Jan 12, 1987	Substantially Equivalent	Bird Products Corp.
K864680	MOBIL 02	Jan 09, 1987	Substantially Equivalent	Roman Laboratories, Inc.
K863339	DURA NEB(TM) 2000 PORTABLE COMPRESSOR	Oct 07, 1986	Substantially Equivalent	Thera Tec, Inc.
K862628	BUNN MODEL 510 MEDICATION COMPRESSOR	Aug 07, 1986	Substantially Equivalent	The John Bunn Co.
K861865	ERIE-NEB	Jul 01, 1986	Substantially Equivalent	Erie Medical
K852622	AEROSOL ONE	Apr 24, 1986	Substantially Equivalent	Ashai Co. , Ltd.
K854747	TRAVONEB MODEL # TONE 1	Feb 24, 1986	Substantially Equivalent	Travomed, Inc.
K853944	CPAP BLOWER	Nov 21, 1985	Substantially Equivalent	American Air & Process, Inc.
K854306	OHMEDA CPU AIR COMPRESSOR MODEL 3350	Nov 01, 1985	Substantially Equivalent	Ohmeda Medical
K850795	AIR COMPRESSOR	May 28, 1985	Substantially Equivalent	Bear Medical Systems, Inc.
K844956	AVA-MIST PORTABLE AIR COMPRESSOR	Feb 14, 1985	Substantially Equivalent	Avatron, Inc.
K841537	IMPACT MODEL 601	May 31, 1984	Substantially Equivalent	Impact Instrumentation, Inc.
K833501	MEDI-MIST PORTA. COMPRESSOR DRIVEN	Dec 12, 1983	Substantially Equivalent	Mountain Medical Equipment, Inc.
K832220	TRAVELER NEBULIZING SYSTEM	Sep 26, 1983	Substantially Equivalent	Medix of Florida, Inc.
K832072	VITA-MIST AIR COMPRESSOR & NEBULIZER	Sep 12, 1983	Substantially Equivalent	Vita Medics
K830417	RESPI-NEB-AEROSOL SYSTEM	Mar 24, 1983	Substantially Equivalent	Professional Medical Supply, Inc.
K822685	NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY	Sep 21, 1982	Substantially Equivalent	Certified Respiratory Services, Inc.
K822512	REPCO EASY-BREATHER CLINICAL AIR PUMP	Sep 21, 1982	Substantially Equivalent	Repcocarts USA, Inc.
K820079	AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL	Feb 05, 1982	Substantially Equivalent	James L. Geraci & Associates, Inc.
K813311	COMPRESSOR, AIR, PORTABLE	Dec 31, 1981	Substantially Equivalent	The Biomed Group
K812766	PCS-5 ACCESSORIES	Dec 17, 1981	Substantially Equivalent	Timeter Instrument Corp.
K812767	SNIFF AIR COMPRESSOR #SF-6	Nov 27, 1981	Substantially Equivalent	Timeter Instrument Corp.
K802253	AIR COMPRESSOR ADAPTOR KIT	Sep 26, 1980	Substantially Equivalent	Hudson Oxygen Therapy Sales Co.
K801286	PORTA-NEB(R) 310	Jul 08, 1980	Substantially Equivalent	E.B.E. Research & Mfg., Inc.
K800534	MODEL 52 BUNN DRY AIR SUPPLY	Mar 25, 1980	Substantially Equivalent	Greene & Kellogg, Inc.
K792457	COMPRESSOR	Feb 05, 1980	Substantially Equivalent	Pneupac , Ltd.
K790912	ARIDYNE 3500	May 21, 1979	Substantially Equivalent	Timeter Instrument Corp.
K781213	COMPRESSOR, AIR, MINI-SILENT	Jul 27, 1978	Substantially Equivalent	The John Bunn Co.
K771707	ADIDYNE 3000	Sep 26, 1977	Substantially Equivalent	Timeter Instrument Corp.
K761294	RESPIRATORY BLOWER	Jan 03, 1977	Substantially Equivalent	Harris-Lake, Inc.