BTS
6 FDA 510(k) clearances · Product code
91 daysmedian time to decision
97 days90th percentile
6clearances measured
FDA profile
- Official device name
- Tube, Bronchial (W/Wo Connector)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5720
- Medical specialty
- Anesthesiology
- Flags
- Life-sustaining
- Adverse events (MAUDE)
- 2021: 110 · 2022: 140 · 2023: 162 · 2024: 172 · 2025: 207 · 2026: 111
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 |
|---|---|---|
| RUSCH SINGLE LUMEN BRONCHIAL TUVBE SET, STERILE, FOR LEFT & RIGHT SIDED BRONCHIAL INTUBATION (K953963) | Rusch, Inc. | 1995-11-27 |
| RUSCH ENDOBRONCHIAL TUBE SETS (K951091) | Rusch Intl. | 1995-06-08 |
| MODIFIED ENDOBRONCHIAL TUBE (K902116) | Concord/Portex | 1990-08-03 |
| ENDOBRONCHIAL TWIN LUMEN TUBE (K834565) | Portex, Inc. | 1984-01-17 |
| BRONCHOSCOPY TUBE W/ULTRA LOCUFF (K833297) | Surgitek | 1983-12-27 |
| BRONCHO-CATH (K771219) | Mallinckrodt Critical Care | 1977-08-04 |
Track BTS automatically
Every clearance here is in the API, with alerts when new ones post.