Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
FPY — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
74 daysmedian FDA review time
389 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930759 | CP & S STERILE BURN SHEET | Consolidated Products & Services, Inc. | 1994-01-21 | 343 | 0 |
| K921470 | BURNSHIELD FIRE BLANKET | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 | 389 | 0 |
| K921471 | BURNSHIELD TRAUMA DRESSING | Levtrade Intl. (Pty) , Ltd. | 1993-04-20 | 389 | 0 |
| K926290 | BURN SHEET | Gam Industries, Inc. | 1993-04-20 | 127 | 0 |
| K900443 | BURNS CASUALTY SHEET LIMB WRAP | Pilgrim Medical Services | 1990-07-03 | 154 | 0 |
| K900442 | BURNS CASUALTY SHEET BURN ROLL | Pilgrim Medical Services | 1990-07-03 | 154 | 0 |
| K900441 | BURNS CASUALTY SHEET | Pilgrim Medical Services | 1990-07-03 | 154 | 0 |
| K871740 | LYOSHEET SURGICAL SHEET FOR BURNS | Acme United Corp. | 1987-06-09 | 35 | 0 |
| K853145 | KENDALL CURITY BURN PAD | The Kendal Co. | 1985-08-30 | 32 | 0 |
| K841898 | FIRST RESPONSE EMERG. MEDICSL - BURNS | Reed Products, Inc. | 1984-08-14 | 99 | 0 |
| K820994 | ABSORB FURN SHEET | American Convertors Div., American Pharmaseal | 1982-05-13 | 35 | 0 |
| K800064 | WATER JEL FIRE BLANKET | Trilling Resources, Ltd. | 1980-03-25 | 74 | 0 |
| K792433 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | 1979-12-20 | 22 | 0 |
| K792432 | TEMPORARY BURN SHEET WITH PERFORATED | American Medical Disposable, Inc. | 1979-12-20 | 22 | 0 |
| K780418 | BURN DRESSING PAD | The Owenby Co. | 1978-04-10 | 27 | 0 |
| K760365 | BLANKET, BURN | Winn Hirsch & Assoc. | 1976-08-11 | 8 | 0 |
| K760210 | BLANKET, WATER-JEL FIRE | American Safety | 1976-08-11 | 30 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda