FPY
17 FDA 510(k) clearances · Product code
74 daysmedian time to decision
389 days90th percentile
17clearances measured
FDA profile
- Official device name
- Sheet, Burn
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5180
- Medical specialty
- General Hospital
- Adverse events (MAUDE)
- 1995: 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 |
|---|---|---|
| CP & S STERILE BURN SHEET (K930759) | Consolidated Products & Services, Inc. | 1994-01-21 |
| BURNSHIELD FIRE BLANKET (K921470) | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 |
| BURNSHIELD TRAUMA DRESSING (K921471) | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 |
| BURN SHEET (K926290) | Gam Industries, Inc. | 1993-04-20 |
| BURNS CASUALTY SHEET LIMB WRAP (K900443) | Pilgrim Medical Services | 1990-07-03 |
| BURNS CASUALTY SHEET BURN ROLL (K900442) | Pilgrim Medical Services | 1990-07-03 |
| BURNS CASUALTY SHEET (K900441) | Pilgrim Medical Services | 1990-07-03 |
| LYOSHEET SURGICAL SHEET FOR BURNS (K871740) | Acme United Corp. | 1987-06-09 |
| KENDALL CURITY BURN PAD (K853145) | The Kendal Co. | 1985-08-30 |
| FIRST RESPONSE EMERG. MEDICSL - BURNS (K841898) | Reed Products, Inc. | 1984-08-14 |
| ABSORB FURN SHEET (K820994) | American Convertors Div., American Pharmaseal | 1982-05-13 |
| WATER JEL FIRE BLANKET (K800064) | Trilling Resources, Ltd. | 1980-03-25 |
| TEMPORARY BURN SHEET WITH PERFORATED (K792433) | American Medical Disposable, Inc. | 1979-12-20 |
| TEMPORARY BURN SHEET WITH PERFORATED (K792432) | American Medical Disposable, Inc. | 1979-12-20 |
| BURN DRESSING PAD (K780418) | The Owenby Co. | 1978-04-10 |
| BLANKET, BURN (K760365) | Winn Hirsch & Assoc. | 1976-08-11 |
| BLANKET, WATER-JEL FIRE (K760210) | American Safety | 1976-08-11 |
Track FPY automatically
Every clearance here is in the API, with alerts when new ones post.