Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DEL · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
44 daysmedian FDA review time
52 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K013278 | TINA-QUANT APOLIPOPROTEIN A-1 VER.2 | Roche Diagnostics Corp. | 2001-11-15 | 45 | 0 |
| K901675 | APOLIPOPROTEIN A-I (APO A-I) | Sigma Chemical Co. | 1990-04-26 | 16 | 0 |
| K900124 | APOLIPOPROTEIN B (APO B) | Sigma Chemical Co. | 1990-03-02 | 52 | 0 |
| K895160 | ORTHO *APO A-1 ELISA TEST SYSTEM | Medical Marketing Consultants, Inc. | 1989-10-06 | 44 | 0 |
| K893885 | BACTON TM, BASIC TM, APO A-I REAGENT | Catachem, Inc. | 1989-06-21 | 22 | 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