Product code BTI
- Device name
- Compressor, Air, Portable
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.6250
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131881 | OMBRA TABLE TOP COMPRESSOR | Trudell Medical Intl. | 2013-10-24 |
| K113338 | MEDICAL AIR COMPRESSOR | Oricare, Inc. | 2012-08-10 |
| K091871 | DK50 DS | Ekom S.R.O. | 2009-10-23 |
| K072634 | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | Emg Technology Co., Ltd. | 2008-11-19 |
| K060781 | MEDICAL COMPRESSOR, MODELS DK50 D AND DM | Ekom S.R.O. | 2006-10-03 |
| K051691 | MINIMATE COMPRESSOR | Precision Medical, Inc. | 2005-12-09 |
| K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | Hamilton Medical AG | 2005-03-14 |
| K041406 | NEWPORT C250 AIR COMPRESSOR MODEL C250 | Newport Medical Instruments | 2004-12-15 |
| K041974 | MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER | Med2000 S.R.L. | 2004-08-24 |
| K040220 | MEDICAL AIR COMPRESSOR | eVent Medical, Ltd. | 2004-06-09 |
| K031686 | AEROMIST LT, MODEL HCS15004 | Medline Industries, Inc. | 2004-01-21 |
| K031413 | VIGORMIST COMPRESSOR NEBULIZER | Vega Technologies, Inc. | 2003-10-07 |
| K023354 | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Siemens Elema AB | 2003-09-05 |
| K020797 | PULMO-MIST COMPRESSOR MODEL # 4323 | Nidek Medical Products, Inc. | 2002-05-03 |
| K013027 | MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 | Respironics Healthscan, Inc. | 2001-12-06 |
| K002862 | PRONEB ULTRA MODEL NUMBER 85B0100 | Pari Holding Co. | 2001-03-13 |
| K002468 | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 | San UP S.A. | 2001-03-02 |
| K982789 | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | Drager, Inc. | 1998-10-29 |
| K963349 | DEVILBISS 8650D | Devilbiss Health Care, Inc. | 1997-06-13 |
| K951926 | ALRECO 40400 | Allan Rehnstrom AB | 1995-12-08 |
| K945478 | AM-50 AEROSOL/MEDICATION AIR COMPRESSOR | Preferred Medical Supply, Inc. | 1995-09-28 |
| K952616 | MICROTIME | Westmed Intl. | 1995-09-27 |
| K946039 | MODEL #5000 PULMO PLUS | International Medical Systems | 1995-06-16 |
| K940630 | 503 MAXI COMPRESSOR | Medical Industries America, Inc. | 1995-02-21 |
| K930509 | PM PUMP COMPRESSOR | Precision Medical, Inc. | 1994-10-28 |
| K925010 | NEBULIZER PUMP, POWERED, MODEL 1110 | Thomas Industries | 1994-05-27 |
| K925011 | NEBULIZER PUMP, POWERED MODEL 1180 | Thomas Industries | 1994-01-12 |
| K931015 | DEVILBISS MODEL 4650 COMPRESSOR NEUBULIZER | Devilbiss Health Care, Inc. | 1993-09-30 |
| K913097 | SAM ST | Ferguson Medical | 1992-12-11 |
| K922623 | NEBULIZER SYSTEM | Healthdyne, Inc. | 1992-12-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10197344149100 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-03 |
| 10197344149094 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-03 |
| 10197344149087 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-03 |
| 10197344149070 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-11-03 |
| 10197344135592 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-14 |
| 10197344154203 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-06 |
| 10197344154197 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-06 |
| 10197344154180 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-06 |
| 10197344135585 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-08-06 |
| 10197344135578 | MEDLINE | MEDLINE INDUSTRIES, INC. | 2025-07-28 |
| 07640214641892 | EVair | IMT Analytics AG | 2020-07-23 |
| 07640214641854 | EVair | IMT Analytics AG | 2020-07-23 |
| 10637320081005 | VORTRAN Medical Air Compressor | VORTRAN MEDICAL TECHNOLOGY 1, INC | 2017-11-30 |
| M368JB01201001 | JOHN BUNN | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| M368JB01120711 | JOHN BUNN | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| M36857101 | JOHN BUNN | GF HEALTH PRODUCTS, INC. | 2016-08-31 |
| 08586014620707 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620639 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620646 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620653 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620660 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620677 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620684 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620813 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620691 | DK50 DS | EKOM spol. s r.o. | 2016-05-26 |
| 08586014620165 | C235 | EKOM spol. s r.o. | 2016-05-13 |
| 08586014620158 | C235 | EKOM spol. s r.o. | 2016-05-13 |
| 08586014620141 | C235 | EKOM spol. s r.o. | 2016-05-13 |
| 08586014620134 | C235 | EKOM spol. s r.o. | 2016-05-13 |
| 08586014620127 | C235 | EKOM spol. s r.o. | 2016-05-13 |