Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MKU — Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
173 daysmedian FDA review time
335 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K192517 | Psychemedics Microplate EIA for Cotinine in Hair | Psychemedics Corporation | 2020-04-22 | 222 | 0 |
| K192299 | LZI Cotinine II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019-11-21 | 90 | 0 |
| K062565 | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE | Princeton BioMeditech Corp. | 2007-02-20 | 173 | 0 |
| K021944 | COZART EIA COTININE URINE KIT | Cozart Bioscience , Ltd. | 2003-05-14 | 335 | 0 |
| K974534 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-18 | 167 | 0 |
| K974234 | MICRO-PLATE COTININE EIA | OraSure Technologies, Inc. | 1998-05-14 | 183 | 0 |
| K972481 | AUTO-LYTE COTININE EIA | OraSure Technologies, Inc. | 1997-10-21 | 111 | 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