Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CIW · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
212 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931559 | DMA AMYLASE PROCEDURE | Data Medical Associates, Inc. | 1993-10-28 | 212 | 0 |
| K924339 | OLYMPUS AMYLASE REAGENT | Olympus Corp. | 1992-10-19 | 52 | 0 |
| K884382 | AMYLASE TEST (AMYL) ITEM NUMBER: 65653 | Em Diagnostic Systems, Inc. | 1989-01-11 | 85 | 0 |
| K850639 | ENZYMATIC ALPHA-AMYLASE REAGENT KIT | Bio-Analytics Laboratories, Inc. | 1985-03-05 | 14 | 0 |
| K812027 | KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) | Eastman Kodak Company | 1981-08-03 | 14 | 1 |
| K810584 | PHADEBAS ISOAMYLASE TEST | Pharmacia, Inc. | 1981-05-13 | 70 | 0 |
| K810669 | PANTRAK E.K. | Calbiochem-Behring Corp. | 1981-03-31 | 19 | 0 |
| K782032 | UNITEST AMYLASE | Boehringer Mannheim Corp. | 1979-03-02 | 86 | 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