Miromatrix Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Miromatrix Medical, Inc.” (first 2014, latest 2017), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 2 | 100 |
| 2015 | 2 | 74 |
| 2016 | 1 | 117 |
| 2017 | 1 | 154 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Miromatrix Medical, Inc. took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 150 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTM | Mesh, Surgical | 2 | 2 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 2 | 2 |
| OXH | Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | 2 | 2 |
Review panels
Most recent Miromatrix Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162570 | Miromatrix Biological Mesh TW | FTM | 2017-02-16 | 154 |
| K160400 | Miromatrix Biological Mesh | OXH | 2016-06-08 | 117 |
| K150341 | Miromatrix Biological Mesh RS | OXH | 2015-05-12 | 90 |
| K143426 | Wound Matrix TF | KGN | 2015-01-27 | 57 |
| K140510 | MIROMATRIX WOUND MATRIX | KGN | 2014-06-19 | 111 |
| K134033 | MIROMATRIX BIOLOGICAL MESH | FTM | 2014-03-31 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Miromatrix Medical, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Miromatrix Medical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03232333: MIRODERM H2H DFU Study (Completed, started 2017-07-21)
- NCT02436681: Miromatrix Biological Mesh for Hiatal Hernia Repair (Completed, started 2015-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Miromatrix Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Miromatrix Medical, Inc.” (first 2014, latest 2017), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Miromatrix Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Miromatrix Medical, Inc. is 100 days.
Which FDA product codes appear under Miromatrix Medical, Inc.?
The most frequent FDA product codes under this applicant name are FTM (Mesh, Surgical, 2); KGN (Wound Dressing With Animal-Derived Material(S), 2); OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery, 2).
Next steps
- See all 6 Miromatrix Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FTM, Miromatrix Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.