BTC
19 FDA 510(k) clearances · Product code
37 daysmedian time to decision
117 days90th percentile
19clearances measured
FDA profile
- Official device name
- Bag, Reservoir
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5320
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 2001: 2 · 2003: 6 · 2005: 2 · 2007: 40 · 2010: 47 · 2017: 12
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 |
|---|---|---|
| PeDIA (K181424) | Pedia, LLC | 2018-09-25 |
| REBREATHER BAGS (K940220) | Zefon Medical Products | 1994-05-27 |
| PRECISION MED PRODUCTS, LTD. BREATHING BAGS (K932496) | Precision Med Products, Ltd. | 1993-07-16 |
| BREATHING BAGS (K932581) | Med-Plastics Intl., Inc. | 1993-07-16 |
| BREATHING BAGS (K932584) | Merit Medical Systems, Inc. | 1993-07-16 |
| BREATHING BAGS (K932191) | Life Shield Healthcare Products, Inc. | 1993-07-02 |
| ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (K894906) | Med-Tek Corp. | 1989-09-18 |
| KING SYSTEMS, BREATHING BAG (K880680) | King Systems Corp. | 1988-03-03 |
| VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (K864822) | Surgidyne, Inc. | 1987-01-15 |
| ROLLED NECK W/PLUG (K841411) | Warne Surgical Products, Ltd. | 1984-04-18 |
| ROLLED NECK W/TAP (K841412) | Warne Surgical Products, Ltd. | 1984-04-18 |
| COUPLING/VALVE (K830399) | Khi, Inc. | 1983-03-10 |
| ARTEC TWIST VALVE (K830056) | Artec Environmental Monitoring Division | 1983-03-09 |
| VOLUMETRIC CONTROLLER (K822216) | Quest Medical, Inc. | 1982-08-16 |
| ANESTHESIA BREATHING BAG, VARIOUS SIZES (K822116) | Life Design Systems, Inc. | 1982-08-16 |
| ESPREE', BREATHING BAG (K821309) | Esp Plastics, Inc. | 1982-05-21 |
| DISPOSAL LITER BREATHING BAG (K800155) | Dryden Corp. | 1980-02-21 |
| THREE LITER BAG #M-512 (K791910) | Mem Medical, Inc. | 1979-10-09 |
| PARA-VENT (K791463) | Cameron Medical Corp. | 1979-09-17 |
Track BTC automatically
Every clearance here is in the API, with alerts when new ones post.