BTI · Compressor, Air, Portable
Anesthesiology · 21 CFR 868.6250 · Class 2
Overview
| Product Code | BTI |
|---|---|
| Device Name | Compressor, Air, Portable |
| Regulation | 21 CFR 868.6250 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
Identification
A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.
Cleared Devices (74)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | Trudell Medical Intl. | Oct 24, 2013 | SESE |
| K113338 | MEDICAL AIR COMPRESSOR | Oricare, Inc. | Aug 10, 2012 | SESE |
| K091871 | DK50 DS | Ekom S.R.O. | Oct 23, 2009 | SESE |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | Emg Technology Co., Ltd. | Nov 19, 2008 | SESE |
| K060781 | MEDICAL COMPRESSOR, MODELS DK50 D AND DM | Ekom S.R.O. | Oct 3, 2006 | SESE |
| K051691 | MINIMATE COMPRESSOR | Precision Medical, Inc. | Dec 9, 2005 | SESE |
| K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | Hamilton Medical AG | Mar 14, 2005 | SESE |
| K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | Newport Medical Instruments | Dec 15, 2004 | SESE |
| K041974 | MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER | Med2000 S.R.L. | Aug 24, 2004 | SESE |
| K040220 | MEDICAL AIR COMPRESSOR | eVent Medical, Ltd. | Jun 9, 2004 | SESE |
| K031686 | AEROMIST LT, MODEL HCS15004 | Medline Industries, Inc. | Jan 21, 2004 | SESE |
| K031413 | VIGORMIST COMPRESSOR NEBULIZER | Vega Technologies, Inc. | Oct 7, 2003 | SESE |
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Siemens Elema AB | Sep 5, 2003 | SESE |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | Nidek Medical Products, Inc. | May 3, 2002 | SESE |
| K013027 | MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 | Respironics Healthscan, Inc. | Dec 6, 2001 | SESE |
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | Pari Holding Co. | Mar 13, 2001 | SESE |
| K002468 | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 | San UP S.A. | Mar 2, 2001 | SESE |
| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | Drager, Inc. | Oct 29, 1998 | SESE |
| K963349 | DEVILBISS 8650D | Devilbiss Health Care, Inc. | Jun 13, 1997 | SESE |
| K951926 | ALRECO 40400 | Allan Rehnstrom AB | Dec 8, 1995 | SESE |
| K945478 | AM-50 AEROSOL/MEDICATION AIR COMPRESSOR | Preferred Medical Supply, Inc. | Sep 28, 1995 | SESE |
| K952616 | MICROTIME | Westmed Intl. | Sep 27, 1995 | SESE |
| K946039 | MODEL #5000 PULMO PLUS | International Medical Systems | Jun 16, 1995 | SESE |
| K940630 | 503 MAXI COMPRESSOR | Medical Industries America, Inc. | Feb 21, 1995 | SESE |
| K930509 | PM PUMP COMPRESSOR | Precision Medical, Inc. | Oct 28, 1994 | SESE |
| K925010 | NEBULIZER PUMP, POWERED, MODEL 1110 | Thomas Industries | May 27, 1994 | SESE |
| K925011 | NEBULIZER PUMP, POWERED MODEL 1180 | Thomas Industries | Jan 12, 1994 | SESE |
| K931015 | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER | Devilbiss Health Care, Inc. | Sep 30, 1993 | SESE |
| K913097 | SAM ST | Ferguson Medical | Dec 11, 1992 | SESE |
| K922623 | NEBULIZER SYSTEM | Healthdyne, Inc. | Dec 1, 1992 | SESE |
| K920954 | AIR STAR | Infrasonics Corp. | Aug 3, 1992 | SESE |
| K902520 | AIR PLUS NEBULIZER | Diamond Medical Equipment, Inc. | Mar 4, 1991 | SESE |
| K904045 | #504 MINI COMPRESSOR | Medical Industries America, Inc. | Feb 12, 1991 | SESE |
| K902184 | MAXI ASPIRATOR | Medical Industries America, Inc. | Feb 12, 1991 | SESE |
| K902762 | PM14 SOFT AIR COMPRESSOR | Precision Medical, Inc. | Jul 30, 1990 | SESE |
| K900686 | MAXI COMPRESSORS | Medical Industries America, Inc. | Apr 26, 1990 | SESE |
| K894831 | PORTABLE AIR COMPRESSOR MODEL NUMBER 8125 | Equi-Tron Mfg., Inc. | Oct 24, 1989 | SESE |
| K883829 | TURBO AIR COMPRESSOR 8000 | Necon Medical, Inc. | Mar 23, 1989 | SESE |
| K884722 | LUMINEB I | Lumiscope Co., Inc. | Feb 3, 1989 | SESE |
| K883704 | MULTIICHALLENGE NEBULIZER SYSTEM | Biotrine Corp. | Nov 28, 1988 | SESE |
| K883132 | NEBULIZER PUMP POWERED MODELS 020 AND 050 | Travelneb, Inc. | Oct 18, 1988 | SESE |
| K873677 | ECONO-MIST PORTABLE COMPRESSOR DRIVEN NEBULIZER | Mountain Medical Equipment, Inc. | Oct 20, 1987 | SESE |
| K871829 | SIEMENS DRY AIR COMPRESSOR | Siemens Elema AB | Jun 15, 1987 | SESE |
| K870428 | AEROSOL ONE, NEBULIZER PUMP | Ashai Co. , Ltd. | May 15, 1987 | SESE |
| K864547 | BIRD 6500 AIR COMPRESSOR | Bird Products Corp. | Jan 12, 1987 | SESE |
| K864680 | MOBIL 02 | Roman Laboratories, Inc. | Jan 9, 1987 | SESE |
| K863339 | DURA NEB(TM) 2000 PORTABLE COMPRESSOR | Thera Tec, Inc. | Oct 7, 1986 | SESE |
| K862628 | BUNN MODEL 510 MEDICATION COMPRESSOR | The John Bunn Co. | Aug 7, 1986 | SESE |
| K861865 | ERIE-NEB | Erie Medical | Jul 1, 1986 | SESE |
| K852622 | AEROSOL ONE | Ashai Co. , Ltd. | Apr 24, 1986 | SESE |
| K854747 | TRAVONEB MODEL # TONE 1 | Travomed, Inc. | Feb 24, 1986 | SESE |
| K853944 | CPAP BLOWER | American Air & Process, Inc. | Nov 21, 1985 | SESE |
| K854306 | OHMEDA CPU AIR COMPRESSOR MODEL 3350 | Ohmeda Medical | Nov 1, 1985 | SESE |
| K850795 | AIR COMPRESSOR | Bear Medical Systems, Inc. | May 28, 1985 | SESE |
| K844956 | AVA-MIST PORTABLE AIR COMPRESSOR | Avatron, Inc. | Feb 14, 1985 | SESE |
| K841537 | IMPACT MODEL 601 | Impact Instrumentation, Inc. | May 31, 1984 | SESE |
| K833501 | MEDI-MIST PORTA. COMPRESSOR DRIVEN | Mountain Medical Equipment, Inc. | Dec 12, 1983 | SESE |
| K832220 | TRAVELER NEBULIZING SYSTEM | Medix of Florida, Inc. | Sep 26, 1983 | SESE |
| K832072 | VITA-MIST AIR COMPRESSOR & NEBULIZER | Vita Medics | Sep 12, 1983 | SESE |
| K830417 | RESPI-NEB-AEROSOL SYSTEM | Professional Medical Supply, Inc. | Mar 24, 1983 | SESE |
| K822685 | NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY | Certified Respiratory Services, Inc. | Sep 21, 1982 | SESE |
| K822512 | REPCO EASY-BREATHER CLINICAL AIR PUMP | Repcocarts USA, Inc. | Sep 21, 1982 | SESE |
| K820079 | AIRMED PNEUMATIC EQUIP. FILTRA/CONTROL | James L. Geraci & Associates, Inc. | Feb 5, 1982 | SESE |
| K813311 | COMPRESSOR, AIR, PORTABLE | The Biomed Group | Dec 31, 1981 | SESE |
| K812766 | PCS-5 ACCESSORIES | Timeter Instrument Corp. | Dec 17, 1981 | SESE |
| K812767 | SNIFF AIR COMPRESSOR #SF-6 | Timeter Instrument Corp. | Nov 27, 1981 | SESE |
| K802253 | AIR COMPRESSOR ADAPTOR KIT | Hudson Oxygen Therapy Sales Co. | Sep 26, 1980 | SESE |
| K801286 | PORTA-NEB(R) 310 | E.B.E. Research & Mfg., Inc. | Jul 8, 1980 | SESE |
| K800534 | MODEL 52 BUNN DRY AIR SUPPLY | Greene & Kellogg, Inc. | Mar 25, 1980 | SESE |
| K792457 | COMPRESSOR | Pneupac , Ltd. | Feb 5, 1980 | SESE |
| K790912 | ARIDYNE 3500 | Timeter Instrument Corp. | May 21, 1979 | SESE |
| K781213 | COMPRESSOR, AIR, MINI-SILENT | The John Bunn Co. | Jul 27, 1978 | SESE |
| K771707 | ADIDYNE 3000 | Timeter Instrument Corp. | Sep 26, 1977 | SESE |
| K761294 | RESPIRATORY BLOWER | Harris-Lake, Inc. | Jan 3, 1977 | SESE |
Top Applicants
- Timeter Instrument Corp. — 4 clearances
- Medical Industries America, Inc. — 4 clearances
- Precision Medical, Inc. — 3 clearances
- Thomas Industries — 2 clearances
- The John Bunn Co. — 2 clearances
