Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart G — Miscellaneous](/submissions/AN/subpart-g%E2%80%94miscellaneous) → [21 CFR 868.6250](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6250) → BTI — Compressor, Air, Portable # BTI · Compressor, Air, Portable _Anesthesiology · 21 CFR 868.6250 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI ## Overview - **Product Code:** BTI - **Device Name:** Compressor, Air, Portable - **Regulation:** [21 CFR 868.6250](/submissions/AN/subpart-g%E2%80%94miscellaneous/868.6250) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) ## 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](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K131881.md) | OMBRA TABLE TOP COMPRESSOR | Trudell Medical Intl. | Oct 24, 2013 | SESE | | [K113338](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K113338.md) | MEDICAL AIR COMPRESSOR | Oricare, Inc. | Aug 10, 2012 | SESE | | [K091871](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K091871.md) | DK50 DS | Ekom S.R.O. | Oct 23, 2009 | SESE | | [K072634](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K072634.md) | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | Emg Technology Co., Ltd. | Nov 19, 2008 | SESE | | [K060781](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K060781.md) | MEDICAL COMPRESSOR, MODELS DK50 D AND DM | Ekom S.R.O. | Oct 3, 2006 | SESE | | [K051691](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K051691.md) | MINIMATE COMPRESSOR | Precision Medical, Inc. | Dec 9, 2005 | SESE | | [K041781](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K041781.md) | VENTILAIR II MEDICAL AIR COMPRESSOR | Hamilton Medical AG | Mar 14, 2005 | SESE | | [K041406](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K041406.md) | NEWPORT C250 AIR COMPRESSOR MODEL C250 | Newport Medical Instruments | Dec 15, 2004 | SESE | | [K041974](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K041974.md) | MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER | Med2000 S.R.L. | Aug 24, 2004 | SESE | | [K040220](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K040220.md) | MEDICAL AIR COMPRESSOR | eVent Medical, Ltd. | Jun 9, 2004 | SESE | | [K031686](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K031686.md) | AEROMIST LT, MODEL HCS15004 | Medline Industries, Inc. | Jan 21, 2004 | SESE | | [K031413](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K031413.md) | VIGORMIST COMPRESSOR NEBULIZER | Vega Technologies, Inc. | Oct 7, 2003 | SESE | | [K023354](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K023354.md) | COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E | Siemens Elema AB | Sep 5, 2003 | SESE | | [K020797](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K020797.md) | PULMO-MIST COMPRESSOR MODEL # 4323 | Nidek Medical Products, Inc. | May 3, 2002 | SESE | | [K013027](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K013027.md) | MISTER NEB NEBULIZER COMPRESSOR, WITH NEBULIZER, MODEL HS123 | Respironics Healthscan, Inc. | Dec 6, 2001 | SESE | | [K002862](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K002862.md) | PRONEB ULTRA MODEL NUMBER 85B0100 | Pari Holding Co. | Mar 13, 2001 | SESE | | [K002468](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K002468.md) | SAN UP S.A. NEBULIZER COMPRESSOR, WITH DISPOSABLE NEBULIZER, MODEL 3050 | San UP S.A. | Mar 2, 2001 | SESE | | [K982789](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K982789.md) | MEDICAL AIR COMPRESSOR, MODEL # 8413419 | Drager, Inc. | Oct 29, 1998 | SESE | | [K963349](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K963349.md) | DEVILBISS 8650D | Devilbiss Health Care, Inc. | Jun 13, 1997 | SESE | | [K951926](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI/K951926.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI](https://fda.innolitics.com/submissions/AN/subpart-g%E2%80%94miscellaneous/BTI) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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