Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Miromatrix Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
111 daysmedian FDA review time
154 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K162570 | Miromatrix Biological Mesh TW | Miromatrix Medical, Inc. | 2017-02-16 | 154 | 0 |
| K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2016-06-08 | 117 | 0 |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015-05-12 | 90 | 0 |
| K143426 | Wound Matrix TF | Miromatrix Medical, Inc. | 2015-01-27 | 57 | 0 |
| K140510 | MIROMATRIX WOUND MATRIX | Miromatrix Medical, Inc. | 2014-06-19 | 111 | 0 |
| K134033 | MIROMATRIX BIOLOGICAL MESH | Miromatrix Medical, Inc. | 2014-03-31 | 90 | 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