FOG
9 FDA 510(k) clearances · Product code
39 daysmedian time to decision
90 days90th percentile
9clearances measured
FDA profile
- Official device name
- Hood, Oxygen, Infant
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5700
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1992: 1 · 2008: 3
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 |
|---|---|---|
| OLYMPUS NA-10J-1 ASPIRATION NEEDLE (K973128) | Olympus America, Inc. | 1997-11-18 |
| BURLEW INFANT HOOD (K962182) | Promedic, Inc. | 1996-07-15 |
| SWIFT INFANT OXYGEN HOOD-REUSABLE (MODIFICATION) (K955482) | Advantage Medical Services, Inc. | 1996-01-30 |
| ENDO-GUARD (K830781) | Jayco Pharmaceuticals | 1983-03-31 |
| DISPOSA-HOOD (K792144) | Utah Medical Products, Inc. | 1979-12-05 |
| OXYGEN HOODS (K791861) | Ann Arbor Plastics, Inc. | 1979-10-04 |
| RT-HOOD (K790860) | Plastics Supplies & Products | 1979-05-29 |
| HOOD, INFANT OXYGEN (K780220) | Shiley, Inc. | 1978-04-10 |
| DUODENOSCOPE, MOLEL TX-6 (K770754) | American Cystocope Makers, Inc. | 1977-04-28 |
Track FOG automatically
Every clearance here is in the API, with alerts when new ones post.