BTK
6 FDA 510(k) clearances · Product code
40 daysmedian time to decision
188 days90th percentile
6clearances measured
FDA profile
- Official device name
- Strap, Head, Gas Mask
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5560
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2003: 2 · 2012: 11
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 |
|---|---|---|
| GENERAL ANESTHESIA SYSTEM (K944949) | Vital Signs, Inc. | 1994-11-14 |
| STRAP, HEAD, GAS MASK (K914335) | Vital Signs, Inc. | 1992-04-02 |
| HEADSTRAP (K854537) | Life Design Systems, Inc. | 1985-12-03 |
| MEDIPART FACE MASK HEADSTRAP MP-9100 (K853573) | Medipart Jerry Alexander | 1985-10-29 |
| HEAD STRAP (K831008) | Medovations, Inc. | 1983-05-09 |
| HEADSTRAP (K810991) | Respironics, Inc. | 1981-04-29 |
Track BTK automatically
Every clearance here is in the API, with alerts when new ones post.