FLI
8 FDA 510(k) clearances · Product code
60 daysmedian time to decision
104 days90th percentile
8clearances measured
FDA profile
- Official device name
- Cabinet, Ethylene-Oxide Gas Aerator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.6100
- Medical specialty
- General Hospital
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 2000: 4 · 2002: 1
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 |
|---|---|---|
| STERI-VAC(TM) AERATOR MODEL XL (K904921) | 3M Health Care, Ltd. | 1990-12-05 |
| GAS-VAK(R) COMBINATION STERILIZER & VENTILATOR (K902906) | Gas-Vak | 1990-10-15 |
| CASTLE MODEL 3341 & 3441 & 4141 GAS AER (K831595) | Castle Co. | 1983-06-15 |
| BEAR JET 150 VENTILATOR (K830165) | Bear Medical Systems, Inc. | 1983-04-12 |
| CASTLE #3241 GAS AERATOR (K813201) | Sybron Corp. | 1981-12-31 |
| EO EVACUATING SYSTEM I (K790677) | Castle Co. | 1979-05-07 |
| CASTLE MODEL 3146 GAS AERATOR (K781484) | Castle Co. | 1978-10-27 |
| PORTAGAS AERATOR (K761341) | Amsco Co. | 1977-02-28 |
Track FLI automatically
Every clearance here is in the API, with alerts when new ones post.