Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Anatech, Ltd. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
34 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882873 | FIELDTEX HEMATOXYLIN | Anatech, Ltd. | 1988-07-28 | 17 | 0 |
| K882874 | ZINC FORMALIN | Anatech, Ltd. | 1988-07-28 | 17 | 0 |
| K882268 | ZINC FORMALIN CONCENTRATE | Anatech, Ltd. | 1988-06-15 | 15 | 0 |
| K881282 | XYLENE | Anatech, Ltd. | 1988-04-05 | 11 | 0 |
| K872663 | DRY-FORM | Anatech, Ltd. | 1987-08-06 | 29 | 0 |
| K872498 | HARRIS HEMATOXYLIN | Anatech, Ltd. | 1987-07-09 | 15 | 0 |
| K872499 | ANATECH HEMATOXYLIN-NORMAL STRENGTH | Anatech, Ltd. | 1987-07-09 | 15 | 0 |
| K872500 | ANATECH HEMATOXYLIN-EXTRA STRENGTH | Anatech, Ltd. | 1987-07-09 | 15 | 0 |
| K870852 | NBF 10% NEUTRAL BUFFERED FORMALIN | Anatech, Ltd. | 1987-03-31 | 28 | 0 |
| K842862 | CB FORMALIN | Anatech, Ltd. | 1984-08-28 | 36 | 0 |
| K842940 | CBA FORMALIN | Anatech, Ltd. | 1984-08-28 | 34 | 0 |
| K842863 | PRO-SOFT DEHYDRANT | Anatech, Ltd. | 1984-08-21 | 29 | 0 |
| K842986 | REFRAX MOUNTING MEDIUM | Anatech, Ltd. | 1984-08-21 | 22 | 0 |
| K842861 | PRO-PAR CLEARANT | Anatech, Ltd. | 1984-08-21 | 29 | 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