BYW
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Device, Rebreathing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5675
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2001: 2 · 2002: 6 · 2003: 2 · 2004: 2 · 2007: 2 · 2012: 6
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| HYPEX (K895274) | Global Business, Inc. | 1990-02-23 |
| SHERWOOD VENTILATORY MUSCLE TRAINER (K802165) | Sherwood Medical Co. | 1980-09-26 |
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Every clearance here is in the API, with alerts when new ones post.