FNY
9 FDA 510(k) clearances · Product code
61 daysmedian time to decision
248 days90th percentile
9clearances measured
FDA profile
- Official device name
- Basin, Emesis
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.6730
- Medical specialty
- General Hospital
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2003: 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 |
|---|---|---|
| AAP DOSIMETRY RELEASE OR BASIN SETS (K832826) | American Hospital Supply Corp. | 1984-04-23 |
| BASIN PACK (K802538) | Texas Medical Products, Inc. | 1980-10-31 |
| STERILE SPONGE BOWLS (K800440) | Premium Plastics, Inc. | 1980-04-29 |
| STERILIZATION PROCESS/PLACENTA BASIN (K792625) | Procter & Gamble Mfg. Co. | 1980-01-16 |
| 8 EMESIS BASIN (K771733) | Bemis Health Care | 1977-09-28 |
| BASIN, RECTANGULAR WASH (K760495) | Landmark Plastics | 1976-11-12 |
| BASIN, ROUND WASH (K760494) | Landmark Plastics | 1976-11-12 |
| BASIN, LARGE OR SMALL (K760492) | Landmark Plastics | 1976-11-12 |
| BASIN, STERILE (#3200) (K760085) | Concord Laboratories, Inc. | 1976-07-20 |
Track FNY automatically
Every clearance here is in the API, with alerts when new ones post.