Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Devetec, 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) |
|---|---|---|---|---|---|
| K894045 | MODIFIED POLYCHROME IV STAIN | Devetec, Inc. | 1989-07-25 | 48 | 0 |
| K873594 | TIF FECAL TEST | Devetec, Inc. | 1987-09-29 | 25 | 0 |
| K870988 | PRICE'S ACID-FAST STAIN | Devetec, Inc. | 1987-03-30 | 19 | 0 |
| K854176 | POLYCHROME IV STAIN | Devetec, Inc. | 1985-10-31 | 16 | 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