FDA product code BYW: Device, Rebreathing
BYW is the FDA product code for device, rebreathing. It is a Class I device, regulated under 21 CFR 868.5675 and reviewed by the Anesthesiology panel. FDA has cleared 2 510(k) submissions under BYW, from 2 different applicants. The average 510(k) review took 101 days (median 101). FDA has posted 1 recall for BYW devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Rebreathing |
| Device class | Class I |
| Regulation | 21 CFR 868.5675 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every BYW clearance
Top BYW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Global Business, Inc. | 1 | 1990-02-23 |
| Sherwood Medical Co. | 1 | 1980-09-26 |
Most recent BYW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895274 | Global Business, Inc. | HYPEX | 1990-02-23 | 184 |
| K802165 | Sherwood Medical Co. | SHERWOOD VENTILATORY MUSCLE TRAINER | 1980-09-26 | 18 |
Recalls for BYW devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2006-10-31.
Frequently asked questions
What is FDA product code BYW?
BYW is the FDA product code for device, rebreathing. It is a Class I device, regulated under 21 CFR 868.5675 and reviewed by the Anesthesiology panel.
What device class is BYW?
Class I, regulation 21 CFR 868.5675. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code BYW?
Across 2 cleared submissions the average was 101 days from receipt to decision (median 101).
Which companies have the most BYW clearances?
Global Business, Inc. (1); Sherwood Medical Co. (1).
Have BYW devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2006-10-31.
Next steps
- Run an FDA pathway report with predicate devices for product code BYW
- Run a recall and safety report across every BYW manufacturer
- Watch product code BYW 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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