Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Accumetrics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
167 daysmedian FDA review time
420 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFY | Accumetrics, Inc. | 2015-07-24 | 420 | 1 |
| K051231 | VERIFYNOW-P2Y12 ASSAY | Accumetrics, Inc. | 2005-08-05 | 84 | 3 |
| K042423 | VERIFYNOW-ASPIRIN ASSAY | Accumetrics, Inc. | 2004-10-06 | 29 | 0 |
| K012701 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA | Accumetrics, Inc. | 2002-06-12 | 302 | 1 |
| K013596 | MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY | Accumetrics, Inc. | 2002-05-16 | 197 | 2 |
| K011337 | ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA) | Accumetrics, Inc. | 2001-10-16 | 167 | 2 |
| K992531 | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTI | Accumetrics, Inc. | 1999-12-20 | 145 | 3 |
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