FDA product code BYR: Transducer, Gas Pressure, Differential
BYR is the FDA product code for transducer, gas pressure, differential. It is a Class I device, regulated under 21 CFR 868.2875 and reviewed by the Anesthesiology panel. FDA has cleared 3 510(k) submissions under BYR, from 3 different applicants. The average 510(k) review took 37 days (median 19).
Classification
| Field | Value |
|---|---|
| Device name | Transducer, Gas Pressure, Differential |
| Device class | Class I |
| Regulation | 21 CFR 868.2875 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYR clearance
Top BYR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Bicore Monitoring Systems | 1 | 1990-02-22 |
| Medical Measurements, Inc. | 1 | 1980-08-14 |
| Draeger Medical, Inc. | 1 | 1979-03-07 |
Most recent BYR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K896718 | Bicore Monitoring Systems | BICORE VARIFLEX(R) FLOW TRANSDUCER | 1990-02-22 | 85 |
| K801880 | Medical Measurements, Inc. | MMI/GAELTEC SERIES 8T DIFF. PRESS. TRANS | 1980-08-14 | 7 |
| K790334 | Draeger Medical, Inc. | DRAGER ORM | 1979-03-07 | 19 |
Recalls for BYR devices
openFDA lists no recalls for product code BYR.
Frequently asked questions
What is FDA product code BYR?
BYR is the FDA product code for transducer, gas pressure, differential. It is a Class I device, regulated under 21 CFR 868.2875 and reviewed by the Anesthesiology panel.
What device class is BYR?
Class I, regulation 21 CFR 868.2875. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYR?
Across 3 cleared submissions the average was 37 days from receipt to decision (median 19).
Which companies have the most BYR clearances?
Bicore Monitoring Systems (1); Medical Measurements, Inc. (1); Draeger Medical, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code BYR
- Run a recall and safety report across every BYR manufacturer
- Watch product code BYR 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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