Atlas FDA

BTI

74 FDA 510(k) clearances · Product code

87 daysmedian time to decision
324 days90th percentile
74clearances measured

FDA profile

Official device name
Compressor, Air, Portable
Device class
Class II (moderate risk)
Regulation
21 CFR 868.6250
Medical specialty
Anesthesiology
Adverse events (MAUDE)
2021: 278 · 2022: 248 · 2023: 325 · 2024: 166 · 2025: 120 · 2026: 323
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
OMBRA TABLE TOP COMPRESSOR (K131881)Trudell Medical Intl.2013-10-24
MEDICAL AIR COMPRESSOR (K113338)Oricare, Inc.2012-08-10
DK50 DS (K091871)Ekom S.R.O.2009-10-23
EMG TRITON -COMP,MODEL NCA01-XXX SERIES (K072634)Emg Technology Co., Ltd.2008-11-19
MEDICAL COMPRESSOR, MODELS DK50 D AND DM (K060781)Ekom S.R.O.2006-10-03
MINIMATE COMPRESSOR (K051691)Precision Medical, Inc.2005-12-09
VENTILAIR II MEDICAL AIR COMPRESSOR (K041781)Hamilton Medical AG2005-03-14
NEWPORT C250 AIR COMPRESSOR MODEL C250 (K041406)Newport Medical Instruments2004-12-15
MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (K041974)Med2000 S.R.L.2004-08-24
MEDICAL AIR COMPRESSOR (K040220)eVent Medical, Ltd.2004-06-09
AEROMIST LT, MODEL HCS15004 (K031686)Medline Industries, Inc.2004-01-21
VIGORMIST COMPRESSOR NEBULIZER (K031413)Vega Technologies, Inc.2003-10-07
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E (K023354)Siemens Elema AB2003-09-05
PULMO-MIST COMPRESSOR MODEL # 4323 (K020797)Nidek Medical Products, Inc.2002-05-03
MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 (K013027)Respironics Healthscan, Inc.2001-12-06
PRONEB ULTRA MODEL NUMBER 85B0100 (K002862)Pari Holding Co.2001-03-13
SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 (K002468)San UP S.A.2001-03-02
MEDICAL AIR COMPRESSOR, MODEL # 8413419 (K982789)Drager, Inc.1998-10-29
DEVILBISS 8650D (K963349)Devilbiss Health Care, Inc.1997-06-13
ALRECO 40400 (K951926)Allan Rehnstrom AB1995-12-08
AM-50 AEROSOL/MEDICATION AIR COMPRESSOR (K945478)Preferred Medical Supply, Inc.1995-09-28
MICROTIME (K952616)Westmed Intl.1995-09-27
MODEL #5000 PULMO PLUS (K946039)International Medical Systems1995-06-16
503 MAXI COMPRESSOR (K940630)Medical Industries America, Inc.1995-02-21
PM PUMP COMPRESSOR (K930509)Precision Medical, Inc.1994-10-28
NEBULIZER PUMP, POWERED, MODEL 1110 (K925010)Thomas Industries1994-05-27
NEBULIZER PUMP, POWERED MODEL 1180 (K925011)Thomas Industries1994-01-12
DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER (K931015)Devilbiss Health Care, Inc.1993-09-30
SAM ST (K913097)Ferguson Medical1992-12-11
NEBULIZER SYSTEM (K922623)Healthdyne, Inc.1992-12-01
AIR STAR (K920954)Infrasonics Corp.1992-08-03
AIR PLUS NEBULIZER (K902520)Diamond Medical Equipment, Inc.1991-03-04
#504 MINI COMPRESSOR (K904045)Medical Industries America, Inc.1991-02-12
MAXI ASPIRATOR (K902184)Medical Industries America, Inc.1991-02-12
PM14 SOFT AIR COMPRESSOR (K902762)Precision Medical, Inc.1990-07-30
MAXI COMPRESSORS (K900686)Medical Industries America, Inc.1990-04-26
PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 (K894831)Equi-Tron Mfg., Inc.1989-10-24
TURBO AIR COMPRESSOR 8000 (K883829)Necon Medical, Inc.1989-03-23
LUMINEB I (K884722)Lumiscope Co., Inc.1989-02-03
MULTIICHALLENGE NEBULIZER SYSTEM (K883704)Biotrine Corp.1988-11-28
NEBULIZER PUMP POWERED MODELS 020 AND 050 (K883132)Travelneb, Inc.1988-10-18
ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER (K873677)Mountain Medical Equipment, Inc.1987-10-20
SIEMENS DRY AIR COMPRESSOR (K871829)Siemens Elema AB1987-06-15
AEROSOL ONE, NEBULIZER PUMP (K870428)Ashai Co. , Ltd.1987-05-15
BIRD 6500 AIR COMPRESSOR (K864547)Bird Products Corp.1987-01-12
MOBIL 02 (K864680)Roman Laboratories, Inc.1987-01-09
DURA NEB(TM) 2000 PORTABLE COMPRESSOR (K863339)Thera Tec, Inc.1986-10-07
BUNN MODEL 510 MEDICATION COMPRESSOR (K862628)The John Bunn Co.1986-08-07
ERIE-NEB (K861865)Erie Medical1986-07-01
AEROSOL ONE (K852622)Ashai Co. , Ltd.1986-04-24
TRAVONEB MODEL # TONE 1 (K854747)Travomed, Inc.1986-02-24
CPAP BLOWER (K853944)American Air & Process, Inc.1985-11-21
OHMEDA CPU AIR COMPRESSOR MODEL 3350 (K854306)Ohmeda Medical1985-11-01
AIR COMPRESSOR (K850795)Bear Medical Systems, Inc.1985-05-28
AVA-MIST PORTABLE AIR COMPRESSOR (K844956)Avatron, Inc.1985-02-14
IMPACT MODEL 601 (K841537)Impact Instrumentation, Inc.1984-05-31
MEDI-MIST PORTA. COMPRESSOR DRIVEN (K833501)Mountain Medical Equipment, Inc.1983-12-12
TRAVELER NEBULIZING SYSTEM (K832220)Medix of Florida, Inc.1983-09-26
VITA-MIST AIR COMPRESSOR & NEBULIZER (K832072)Vita Medics1983-09-12
RESPI-NEB-AEROSOL SYSTEM (K830417)Professional Medical Supply, Inc.1983-03-24
REPCO EASY-BREATHER CLINICAL AIR PUMP (K822512)Repcocarts USA, Inc.1982-09-21
NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY (K822685)Certified Respiratory Services, Inc.1982-09-21
AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL (K820079)James L. Geraci & Associates, Inc.1982-02-05
COMPRESSOR, AIR, PORTABLE (K813311)The Biomed Group1981-12-31
PCS-5 ACCESSORIES (K812766)Timeter Instrument Corp.1981-12-17
SNIFF AIR COMPRESSOR #SF-6 (K812767)Timeter Instrument Corp.1981-11-27
AIR COMPRESSOR ADAPTOR KIT (K802253)Hudson Oxygen Therapy Sales Co.1980-09-26
PORTA-NEB(R) 310 (K801286)E.B.E. Research & Mfg., Inc.1980-07-08
MODEL 52 BUNN DRY AIR SUPPLY (K800534)Greene & Kellogg, Inc.1980-03-25
COMPRESSOR (K792457)Pneupac , Ltd.1980-02-05
ARIDYNE 3500 (K790912)Timeter Instrument Corp.1979-05-21
COMPRESSOR, AIR, MINI-SILENT (K781213)The John Bunn Co.1978-07-27
ADIDYNE 3000 (K771707)Timeter Instrument Corp.1977-09-26
RESPIRATORY BLOWER (K761294)Harris-Lake, Inc.1977-01-03

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Every clearance here is in the API, with alerts when new ones post.