Compressor, Air, Portable
FDA product code BTI · Class II (moderate risk) · 21 CFR 868.6250 · Anesthesiology
74510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Timeter Instrument Corp. 4
- Medical Industries America, Inc. 4
- Precision Medical, Inc. 3
- Ashai Co. , Ltd. 2
- Siemens Elema AB 2
- Thomas Industries 2
- Mountain Medical Equipment, Inc. 2
- Devilbiss Health Care, Inc. 2
- Ekom S.R.O. 2
- The John Bunn Co. 2
- The Biomed Group 1
- James L. Geraci & Associates, Inc. 1
- Certified Respiratory Services, Inc. 1
- Professional Medical Supply, Inc. 1
- Vita Medics 1
- Trudell Medical Intl. 1
- E.B.E. Research & Mfg., Inc. 1
- Greene & Kellogg, Inc. 1
- Bear Medical Systems, Inc. 1
- Ohmeda Medical 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131881 | Ombra Table Top CompressorBTI · Traditional | Trudell Medical Intl. | 10/24/2013SE |
| K113338 | Medical Air CompressorBTI · Traditional | Oricare, Inc. | 08/10/2012SE |
| K091871 | DK50 DSBTI · Special | Ekom S.R.O. | 10/23/2009SE |
| K072634 | Emg Triton -Comp,Model NCA01-XXX SeriesBTI · Traditional | Emg Technology Co., Ltd. | 11/19/2008SE |
| K060781 | Medical Compressor, Models DK50 D and DMBTI · Traditional | Ekom S.R.O. | 10/03/2006SE |
| K051691 | Minimate CompressorBTI · Traditional | Precision Medical, Inc. | 12/09/2005SE |
| K041781 | Ventilair II Medical Air CompressorBTI · Traditional | Hamilton Medical AG | 03/14/2005SE |
| K041406 | Newport C250 Air Compressor Model C250BTI · Traditional | Newport Medical Instruments | 12/15/2004SE |
| K041974 | MED2000 Nebulizer Compressor, Models P3, P4, P5 with NebulizerBTI · Special | Med2000 S.R.L. | 08/24/2004SE |
| K040220 | Medical Air CompressorBTI · Traditional | eVent Medical, Ltd. | 06/09/2004SE |
| K031686 | Aeromist LT, Model HCS15004BTI · Traditional | Medline Industries, Inc. | 01/21/2004SE |
| K031413 | Vigormist Compressor NebulizerBTI · Traditional | Vega Technologies, Inc. | 10/07/2003SE |
| K023354 | Compressor Mini, 115 V, Model 64 81 779 EH81EBTI · Traditional | Siemens Elema AB | 09/05/2003SE |
| K020797 | Pulmo-Mist Compressor Model # 4323BTI · Traditional | Nidek Medical Products, Inc. | 05/03/2002SE |
| K013027 | Mister Neb Nebulizer Compressor, with Nebulizer, Model HS123BTI · Traditional | Respironics Healthscan, Inc. | 12/06/2001SE |
| K002862 | Proneb Ultra Model Number 85B0100BTI · Traditional | Pari Holding Co. | 03/13/2001SE |
| K002468 | San Up S.A. Nebulizer Compressor, with Disposable Nebulizer, Model 3050BTI · Traditional | San UP S.A. | 03/02/2001SE |
| K982789 | Medical Air Compressor, Model # 8413419BTI · Traditional | Drager, Inc. | 10/29/1998SE |
| K963349 | Devilbiss 8650DBTI · Traditional | Devilbiss Health Care, Inc. | 06/13/1997SE |
| K951926 | Alreco 40400BTI · Traditional | Allan Rehnstrom AB | 12/08/1995SE |
| K945478 | AM-50 Aerosol/Medication Air CompressorBTI · Traditional | Preferred Medical Supply, Inc. | 09/28/1995SE |
| K952616 | MicrotimeBTI · Traditional | Westmed Intl. | 09/27/1995SE |
| K946039 | Model #5000 Pulmo PlusBTI · Traditional | International Medical Systems | 06/16/1995SE |
| K940630 | 503 Maxi CompressorBTI · Traditional | Medical Industries America, Inc. | 02/21/1995SE |
| K930509 | PM Pump CompressorBTI · Traditional | Precision Medical, Inc. | 10/28/1994SE |
| K925010 | Nebulizer Pump, Powered, Model 1110BTI · Traditional | Thomas Industries | 05/27/1994SE |
| K925011 | Nebulizer Pump, Powered Model 1180BTI · Traditional | Thomas Industries | 01/12/1994SE |
| K931015 | Devilbiss Model 4650 Compressor NeubulizerBTI · Traditional | Devilbiss Health Care, Inc. | 09/30/1993SE |
| K913097 | Sam STBTI · Traditional | Ferguson Medical | 12/11/1992SE |
| K922623 | Nebulizer SystemBTI · Traditional | Healthdyne, Inc. | 12/01/1992SE |
| K920954 | Air StarBTI · Traditional | Infrasonics Corp. | 08/03/1992SE |
| K902520 | Air Plus NebulizerBTI · Traditional | Diamond Medical Equipment, Inc. | 03/04/1991SE |
| K904045 | #504 Mini CompressorBTI · Traditional | Medical Industries America, Inc. | 02/12/1991SE |
| K902184 | Maxi AspiratorBTI · Traditional | Medical Industries America, Inc. | 02/12/1991SE |
| K902762 | PM14 Soft Air CompressorBTI · Traditional | Precision Medical, Inc. | 07/30/1990SE |
| K900686 | Maxi CompressorsBTI · Traditional | Medical Industries America, Inc. | 04/26/1990SE |
| K894831 | Portable Air Compressor Model Number 8125BTI · Traditional | Equi-Tron Mfg., Inc. | 10/24/1989SE |
| K883829 | Turbo Air Compressor 8000BTI · Traditional | Necon Medical, Inc. | 03/23/1989SE |
| K884722 | Lumineb IBTI · Traditional | Lumiscope Co., Inc. | 02/03/1989SE |
| K883704 | Multiichallenge Nebulizer SystemBTI · Traditional | Biotrine Corp. | 11/28/1988SE |
| K883132 | Nebulizer Pump Powered Models 020 and 050BTI · Traditional | Travelneb, Inc. | 10/18/1988SE |
| K873677 | Econo-Mist Portable Compressor Driven NebulizerBTI · Traditional | Mountain Medical Equipment, Inc. | 10/20/1987SE |
| K871829 | Siemens Dry Air CompressorBTI · Traditional | Siemens Elema AB | 06/15/1987SE |
| K870428 | Aerosol One, Nebulizer PumpBTI · Traditional | Ashai Co. , Ltd. | 05/15/1987SE |
| K864547 | Bird 6500 Air CompressorBTI · Traditional | Bird Products Corp. | 01/12/1987SE |
| K864680 | Mobil 02BTI · Traditional | Roman Laboratories, Inc. | 01/09/1987SE |
| K863339 | Dura Neb(Tm) 2000 Portable CompressorBTI · Traditional | Thera Tec, Inc. | 10/07/1986SE |
| K862628 | Bunn Model 510 Medication CompressorBTI · Traditional | The John Bunn Co. | 08/07/1986SE |
| K861865 | Erie-NebBTI · Traditional | Erie Medical | 07/01/1986SE |
| K852622 | Aerosol OneBTI · Traditional | Ashai Co. , Ltd. | 04/24/1986SE |
| K854747 | Travoneb Model # Tone 1BTI · Traditional | Travomed, Inc. | 02/24/1986SE |
| K853944 | CPAP BlowerBTI · Traditional | American Air & Process, Inc. | 11/21/1985SE |
| K854306 | Ohmeda Cpu Air Compressor Model 3350BTI · Traditional | Ohmeda Medical | 11/01/1985SE |
| K850795 | Air CompressorBTI · Traditional | Bear Medical Systems, Inc. | 05/28/1985SE |
| K844956 | Ava-Mist Portable Air CompressorBTI · Traditional | Avatron, Inc. | 02/14/1985SE |
| K841537 | Impact Model 601BTI · Traditional | Impact Instrumentation, Inc. | 05/31/1984SE |
| K833501 | Medi-Mist Porta. Compressor DrivenBTI · Traditional | Mountain Medical Equipment, Inc. | 12/12/1983SE |
| K832220 | Traveler Nebulizing SystemBTI · Traditional | Medix of Florida, Inc. | 09/26/1983SE |
| K832072 | Vita-Mist Air Compressor & NebulizerBTI · Traditional | Vita Medics | 09/12/1983SE |
| K830417 | Respi-Neb-Aerosol SystemBTI · Traditional | Professional Medical Supply, Inc. | 03/24/1983SE |
| K822685 | Neb-Travel NTS-1000 & NTS-3000 TherapyBTI · Traditional | Certified Respiratory Services, Inc. | 09/21/1982SE |
| K822512 | Repco Easy-Breather Clinical Air PumpBTI · Traditional | Repcocarts USA, Inc. | 09/21/1982SE |
| K820079 | Airmed Pneumatic Equip. Filtra/ControlBTI · Traditional | James L. Geraci & Associates, Inc. | 02/05/1982SE |
| K813311 | Compressor, Air, PortableBTI · Traditional | The Biomed Group | 12/31/1981SE |
| K812766 | PCS-5 AccessoriesBTI · Traditional | Timeter Instrument Corp. | 12/17/1981SE |
| K812767 | Sniff Air Compressor #SF-6BTI · Traditional | Timeter Instrument Corp. | 11/27/1981SE |
| K802253 | Air Compressor Adaptor KitBTI · Traditional | Hudson Oxygen Therapy Sales Co. | 09/26/1980SE |
| K801286 | Porta-Neb(R) 310BTI · Traditional | E.B.E. Research & Mfg., Inc. | 07/08/1980SE |
| K800534 | Model 52 Bunn Dry Air SupplyBTI · Traditional | Greene & Kellogg, Inc. | 03/25/1980SE |
| K792457 | CompressorBTI · Traditional | Pneupac , Ltd. | 02/05/1980SE |
| K790912 | Aridyne 3500BTI · Traditional | Timeter Instrument Corp. | 05/21/1979SE |
| K781213 | Compressor, Air, Mini-SilentBTI · Traditional | The John Bunn Co. | 07/27/1978SE |
| K771707 | Adidyne 3000BTI · Traditional | Timeter Instrument Corp. | 09/26/1977SE |
| K761294 | Respiratory BlowerBTI · Traditional | Harris-Lake, Inc. | 01/03/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0776-2024 Class I | EvAir CPRSR Kit Upgrade: a) DISS/CEE 7/7 230V 50/60 HZ, Model Number M1230849; b)…GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air)… | Datex-Ohmeda, Inc. | 12/29/2023Open, Classified |
| Z-0775-2024 Class I | EVair 03 (Jun-air) air compressor, model numbers: 1609000 and 1609002GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air)… | Datex-Ohmeda, Inc. | 12/29/2023Open, Classified |
| Z-0774-2024 Class I | EVair air compressor, model numbers: M1230849 and M1230847GE HealthCare has become aware of elevated levels of formaldehyde when the EVair or EVair 03 (Jun-Air)… | Datex-Ohmeda, Inc. | 12/29/2023Open, Classified |
| Z-0848-2014 Class II | Compressor Mini To provide a supply of dry, filtered compressed air for a medical…Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. | Maquet Cardiovascular Us Sales, Llc | 12/05/2013Terminated |
| Z-0674-2007 | Medical Air Compressor Model #8413419Compressors not providing sufficient supply pressure to connected medical ventilator | Draeger Medical, Inc. | 01/26/2007Terminated |