FDA product code BXP: Transducer, Gas Flow
BXP is the FDA product code for transducer, gas flow. It is a Class I device, regulated under 21 CFR 868.2885 and reviewed by the Anesthesiology panel. FDA has cleared 7 510(k) submissions under BXP, from 7 different applicants. The average 510(k) review took 93 days (median 73).
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Gas Flow |
| Device class | Class I |
| Regulation | 21 CFR 868.2885 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Top BXP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Unipower Corp. | 1 | 1994-03-31 |
| Medical Fittings, Inc. | 1 | 1992-08-03 |
| Kells Medical, Inc. | 1 | 1984-03-07 |
| The Perkin-Elmer Corp. | 1 | 1980-03-19 |
| Chambers & Sadler Mfg. | 1 | 1978-08-31 |
2 more applicants have BXP clearances. See the full list in Caduvo.
Most recent BXP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K936141 | Unipower Corp. | UNIPOWER RECHARGEABLE BATTERY PACK | 1994-03-31 | 94 |
| K920360 | Medical Fittings, Inc. | TIMOX OXYGEN TIMER | 1992-08-03 | 189 |
| K832678 | Kells Medical, Inc. | PHONATORY FUNCTION ANALYZER PS-77 | 1984-03-07 | 211 |
| K800087 | The Perkin-Elmer Corp. | ULTRASONIC FLOWMETER | 1980-03-19 | 65 |
| K781039 | Chambers & Sadler Mfg. | OXY-ON DIGITAL OXYGEN TIMER | 1978-08-31 | 73 |
Recalls for BXP devices
openFDA lists no recalls for product code BXP.
Frequently asked questions
What is FDA product code BXP?
BXP is the FDA product code for transducer, gas flow. It is a Class I device, regulated under 21 CFR 868.2885 and reviewed by the Anesthesiology panel.
What device class is BXP?
Class I, regulation 21 CFR 868.2885. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BXP?
Across 7 cleared submissions the average was 93 days from receipt to decision (median 73).
Which companies have the most BXP clearances?
Unipower Corp. (1); Medical Fittings, Inc. (1); Kells Medical, Inc. (1); The Perkin-Elmer Corp. (1); Chambers & Sadler Mfg. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BXP
- Run a recall and safety report across every BXP manufacturer
- Watch product code BXP 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.