Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kmi Diagnostics, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
120 daysmedian FDA review time
320 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K010790 | CORTISOL LIA | Kmi Diagnostics, Inc. | 2002-01-29 | 320 | 0 |
| K990073 | CALCITONIN | Kmi Diagnostics, Inc. | 1999-05-11 | 120 | 0 |
| K973900 | TESTOTERONE ELISA | Kmi Diagnostics, Inc. | 1998-02-24 | 133 | 0 |
| K973901 | 17 B-ESTRADIOL (ELISA) | Kmi Diagnostics, Inc. | 1997-11-24 | 41 | 0 |
| K973898 | PROGESTERONE ELISA | Kmi Diagnostics, Inc. | 1997-11-13 | 30 | 0 |
| K973897 | DHEA-S | Kmi Diagnostics, Inc. | 1997-11-13 | 30 | 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