Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JFM · Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
181 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K170065 | ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) | Siemens Healthcare Diagnostics, Inc. | 2017-03-09 | 59 | 1 |
| K152343 | Direct Bilirubin | Randox Laboratories Limited | 2016-02-16 | 181 | 0 |
| K152344 | Total Bilirubin | Randox Laboratories Limited | 2016-01-28 | 162 | 1 |
| K063845 | ADVIA CHEMISTRY TOTAL BILIRUBIN_2 | Bayer Healthcare, LLC | 2007-12-07 | 345 | 0 |
| K053132 | WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23 | Wako Chemicals USA, Inc. | 2005-12-30 | 52 | 0 |
| K053131 | WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-228 | Wako Chemicals USA, Inc. | 2005-12-30 | 52 | 0 |
| K053090 | DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIR | Beckman Coulter, Inc. | 2005-12-16 | 44 | 0 |
| K050266 | DIRECT BILIRUBIN LIQUICOLOR AND TOTAL BILIRUBIN LIQUICOLOR | Stanbio Laboratory | 2005-06-30 | 146 | 0 |
| K970985 | WAKO TOTAL BILIRUBIN V | Wako Chemicals USA, Inc. | 1997-04-21 | 34 | 0 |
| K904660 | ENZYMATIC BILIRUBIN (TOTAL), CATALOGUE NO. 202-14 | Diagnostic Chemicals, Ltd. (Usa) | 1990-11-20 | 36 | 0 |
| K843174 | DRI-STAT ENZYMATIC BILIRUBIN TEST KIT | Beckman Instruments, Inc. | 1984-09-14 | 32 | 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