Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gibson Laboratories, Inc. — 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) |
|---|---|---|---|---|---|
| K955826 | GIBSON ID-M. CAT. | Gibson Laboratories, Inc. | 1996-02-29 | 65 | 0 |
| K953247 | GIBSON ID A.E. TEST | Gibson Laboratories, Inc. | 1995-11-20 | 132 | 0 |
| K905120 | SAF FIXATIVE | Gibson Laboratories, Inc. | 1990-12-17 | 33 | 0 |
| K904773 | P AND T MEDIUM | Gibson Laboratories, Inc. | 1990-12-04 | 43 | 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