Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
The Bfgoodrich Co. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K875253 | BFGOODRICH BIOTHANE NON-ADHERENT DRESSING | The Bfgoodrich Co. | 1988-04-13 | 113 | 0 |
| K872100 | BIOFILM TRANSORBENT ULCER AND WOUND DRESSING | The Bfgoodrich Co. | 1987-06-30 | 29 | 0 |
| K872099 | BIOFILM TRANS. ISLAND, ISLAND ULCER & WOUND DRESS. | The Bfgoodrich Co. | 1987-06-30 | 29 | 0 |
| K872101 | BIOFILM TRANS. POUCH ULCER & WOUND DRESSING | The Bfgoodrich Co. | 1987-06-30 | 29 | 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