Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
NOE — Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
155 daysmedian FDA review time
290 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K203136 | Diazyme PLAC® Test for Lp-PLA2 Activity | Diazyme Laboratories, Inc. | 2021-08-06 | 290 | 0 |
| K141575 | PLAC TEST FOR LP-PLA2 ACTIVITY | Diadexus, Inc. | 2014-12-15 | 186 | 0 |
| K101853 | PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10 | Diadexus, Inc. | 2011-01-03 | 186 | 0 |
| K072599 | PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, M | Diadexus, Inc. | 2007-12-20 | 97 | 7 |
| K062234 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | 2006-09-11 | 40 | 1 |
| K050523 | DIADEXUS PLAC TEST | Diadexus, Inc. | 2005-06-15 | 105 | 0 |
| K040101 | MODIFICATION TO DIADEXUS PLAC TEST | Diadexus, Inc. | 2004-02-05 | 16 | 0 |
| K030477 | DIADEXUS PLAC TEST | Diadexus, Inc. | 2003-07-18 | 155 | 2 |
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