Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
K. W. Griffen 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) |
|---|---|---|---|---|---|
| K961098 | BIO-DRESSING, STERILE ISLAND DRESSING | K. W. Griffen Co. | 1996-05-03 | 45 | 0 |
| K953810 | FLUFF GAUZE BANDAGE, STERILE & NON-STERILE | K. W. Griffen Co. | 1995-09-14 | 37 | 0 |
| K874161 | MODIFIED USE OF TRIANGLE BANDAGE STERILE | K. W. Griffen Co. | 1987-12-04 | 52 | 0 |
| K870258 | BIOSCRUB SURGICAL SCRUB BRUSH | K. W. Griffen Co. | 1987-02-24 | 32 | 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