Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
FLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910656 | WILSON-COOK DISPOSABLE BIOPSY FORCEPS | Wilson-Cook Medical, Inc. | 1991-04-25 | 70 | 0 |
| K855001 | FRESENIUS HEMODIALYSIS MACHINE A1008 BSM | Seratronics, Inc. | 1986-01-21 | 39 | 0 |
| K791164 | NEGATOVE PRESSURE CONVERTOR | Medicorp, Inc. | 1979-10-04 | 101 | 0 |
| K760725 | COIL MACHINE ADAPTER | Gambro, Inc. | 1976-10-27 | 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