Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KWW · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
71 daysmedian FDA review time
163 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST K | Catachem, Inc. | 2007-01-19 | 147 | 0 |
| K051714 | TOTAL BILE ACIDS ASSAY, MODEL DZ042A | Diazyme Laboratories | 2005-12-07 | 163 | 0 |
| K970120 | BILE ACIDS REAGENT SET | Teco Diagnostics | 1997-03-24 | 69 | 0 |
| K872296 | BILE ACIDS REAGENT | Sigma Diagnostics, Inc. | 1987-08-26 | 71 | 0 |
| K803296 | ENDAB CHOLYLGLYCINE ENZYME IMMUNO. KIT | Immunotech Corp. | 1981-01-16 | 17 | 0 |
| K781337 | CONJUGATED BILE ACIDS RIA KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1978-08-11 | 8 | 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