KGB
13 FDA 510(k) clearances · Product code
164 daysmedian time to decision
214 days90th percentile
13clearances measured
FDA profile
- Official device name
- Mask, Oxygen, Non-Rebreathing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5570
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1998: 1 · 1999: 1 · 2000: 2 · 2014: 32 · 2015: 53 · 2016: 22
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 |
|---|---|---|
| POCKET RESCUE (K970688) | Cheen Houng Ent. Co. , Ltd. | 1997-09-26 |
| ULTIMATE SEAL (K960401) | Hans Rudolph, Inc. | 1996-06-20 |
| COMBO MASK (K941336) | Gam Industries, Inc. | 1994-09-09 |
| CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES (K935917) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994-02-04 |
| COMPACT MASK (K932347) | Vital Signs, Inc. | 1994-01-10 |
| NONREBREATHING VALVE (K933583) | Hans Rudolph, Inc. | 1994-01-03 |
| LAERDAL(TM) POCKET MASK, MODIFICATION (K933048) | Laerdal Medical Corp. | 1993-12-02 |
| PROFAST(R)-DENTURE ADHESIVE CREAM (K930336) | Fittydent-Altwirth & Schmitt GmbH | 1993-08-24 |
| NON REBREATHING MASK (K913164) | Specialty Packaging Producs, Inc. | 1992-01-15 |
| MOUTH-TO-MASK VENTILATORY ADJUNCT (K883766) | Medic One | 1988-10-21 |
| OXYGEN MASK, CONCENTRATION AEROSOL MASK (K790162) | Airlife, Inc. | 1979-04-20 |
| OXYGEN MASK W/RESERVOIR BAG (K790161) | Airlife, Inc. | 1979-04-20 |
| MASK, OXYGEN, NONBREATHING (K781414) | Vitalab Products Corp. | 1978-09-07 |
Track KGB automatically
Every clearance here is in the API, with alerts when new ones post.