Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microtest — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K941579 | MODIFIED MICRO TEST MULTI MICROBE MEDIUM (M5) | Microtest | 1994-10-21 | 203 | 0 |
| K921472 | M4-RT TRANSPORT MEDIUM, (M4 MODIFICATION) | Microtest | 1992-05-06 | 48 | 0 |
| K914894 | VIRAPURE, CHLAMYPURE AND MYCOPURE | Microtest | 1991-12-18 | 48 | 0 |
| K910526 | MICROTEST MULTI MICROBE MEDIUM | Microtest | 1991-04-09 | 61 | 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