Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bayer Corp., Agfa Div. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981280 | CP 1000, CURIX HT 330, CLASSIC E.O.S., CURIX HT 530, MAMORAY | Bayer Corp., Agfa Div. | 1998-04-30 | 22 | 0 |
| K974597 | ADC COMPACT (AGFA DIAGNOSTIC CENTER) | Bayer Corp., Agfa Div. | 1998-03-09 | 90 | 1 |
| K964414 | LR 5200 LASER FILM RECORDER | Bayer Corp., Agfa Div. | 1997-01-27 | 83 | 1 |
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