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.
Recent Cleared Devices (20 of 74)
Showing 20 most recent of 74 cleared devices.
| 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 |
Top Applicants
- Medical Industries America, Inc. — 4 clearances
- Timeter Instrument Corp. — 4 clearances
- Precision Medical, Inc. — 3 clearances
- Ashai Co. , Ltd. — 2 clearances
- Devilbiss Health Care, Inc. — 2 clearances
