Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JXO — Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
163 daysmedian FDA review time
414 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K201228 | Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in H | Psychemedics Corporation | 2021-06-25 | 414 | 0 |
| K111925 | PSYCHEMEDICS COCAINE EIA | Psychemedics Corp. | 2012-05-01 | 300 | 0 |
| K923314 | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | Serex, Inc. | 1992-08-24 | 48 | 0 |
| K921140 | STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA | Solarcare Technologies Corp,Inc. | 1992-08-20 | 163 | 0 |
| K915785 | STC DIAGNOSTICS BENZOYLECGONINE EIA | Solarcare Technologies Corp,Inc. | 1992-03-11 | 78 | 0 |
| K913737 | IL TEST(TM) COCAINE | Instrumentation Laboratory CO | 1991-12-03 | 105 | 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