Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Forma Scientific, 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) |
|---|---|---|---|---|---|
| K841631 | MODEL 3014 SUCTION UNIT | Forma Scientific, Inc. | 1984-07-03 | 74 | 0 |
| K823356 | READY-BOX BODY-TEMP MEDIA WARMER MALLIN- | Forma Scientific, Inc. | 1982-12-03 | 24 | 0 |
| K821401 | MALLINCKRODT DIAG. MEDIA WARMER | Forma Scientific, Inc. | 1982-06-17 | 37 | 0 |
| K812826 | FORMA CH/P GAS PROCESSOR | Forma Scientific, Inc. | 1981-10-23 | 15 | 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