BYL
11 FDA 510(k) clearances · Product code
95 daysmedian time to decision
171 days90th percentile
11clearances measured
FDA profile
- Official device name
- Tent, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5700
- Medical specialty
- Anesthesiology
- Adverse events (MAUDE)
- 1997: 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 |
|---|---|---|
| NASCOR IGLOO (K935126) | Nascor Pty. , Ltd. | 1994-10-18 |
| NASCOR OXYDOME (K905627) | Nascor Pty. , Ltd. | 1991-06-03 |
| SPAG PAK (K896608) | Viratek, Inc. | 1990-04-09 |
| DIRD INGANT O2 (BIO 2 HOOD) (K895866) | Bird Products Corp. | 1989-10-27 |
| NOVA OXYGEN TENT (K893713) | Nova Health Systems, Inc. | 1989-08-21 |
| KEYSTONE OXYGEN TENT (K893714) | Keystone Veterinary Supplies, Inc. | 1989-08-21 |
| AEROSOL DELIVERY HOOD (K882396) | Viratek, Inc. | 1988-08-01 |
| MEDI-COMP NEONATAL OXYGEN HOOD (K851666) | Medicomp, Inc. | 1985-08-06 |
| SEA-LONG NECKSEAL & HOOD (K852345) | Safety Sea Systems, Inc. | 1985-06-20 |
| HOO2D SEAT-INFANT (K820640) | Dhd Medical Products Div. Diemolding Corp. | 1982-03-26 |
| MEDIUM SIZE OXYGEN HOOD #1547 (K802653) | Ann Arbor Plastics, Inc. | 1980-11-24 |
Track BYL automatically
Every clearance here is in the API, with alerts when new ones post.