FDA product code BTI: Compressor, Air, Portable
BTI is the FDA product code for compressor, air, portable. It is a Class II device, regulated under 21 CFR 868.6250 and reviewed by the Anesthesiology panel. FDA has cleared 74 510(k) submissions under BTI, from 59 different applicants. The average 510(k) review took 144 days (median 86). FDA has posted 5 recalls for BTI devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Compressor, Air, Portable |
| Device class | Class II |
| Regulation | 21 CFR 868.6250 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BTI clearance
Top BTI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Industries America, Inc. | 4 | 1995-02-21 |
| Timeter Instrument Corp. | 4 | 1981-12-17 |
| Precision Medical, Inc. | 3 | 2005-12-09 |
| Ekom S.R.O. | 2 | 2009-10-23 |
| Siemens Elema AB | 2 | 2003-09-05 |
54 more applicants have BTI clearances. See the full list in Caduvo.
Most recent BTI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K131881 | Trudell Medical Intl. | OMBRA TABLE TOP COMPRESSOR | 2013-10-24 | 121 |
| K113338 | Oricare, Inc. | MEDICAL AIR COMPRESSOR | 2012-08-10 | 270 |
| K091871 | Ekom S.R.O. | DK50 DS | 2009-10-23 | 122 |
| K072634 | Emg Technology Co., Ltd. | EMG TRITON -COMP,MODEL NCA01-XXX SERIES | 2008-11-19 | 428 |
| K060781 | Ekom S.R.O. | MEDICAL COMPRESSOR, MODELS DK50 D AND DM | 2006-10-03 | 195 |
Recalls for BTI devices
5 product recalls in 3 recall events; 3 initiated in the last five years and 3 still open. Most recent: 2023-12-29.
| Year | Recalls |
|---|---|
| 2023 | 3 |
Frequently asked questions
What is FDA product code BTI?
BTI is the FDA product code for compressor, air, portable. It is a Class II device, regulated under 21 CFR 868.6250 and reviewed by the Anesthesiology panel.
What device class is BTI?
Class II, regulation 21 CFR 868.6250. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BTI?
Across 74 cleared submissions the average was 144 days from receipt to decision (median 86).
Which companies have the most BTI clearances?
Medical Industries America, Inc. (4); Timeter Instrument Corp. (4); Precision Medical, Inc. (3); Ekom S.R.O. (2); Siemens Elema AB (2).
Have BTI devices been recalled?
Yes: 5 product recalls across 3 recall events; the most recent began 2023-12-29.
Next steps
- Run an FDA pathway report with predicate devices for product code BTI
- Run a recall and safety report across every BTI manufacturer
- Watch product code BTI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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