Reprise Biomedical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Reprise Biomedical, Inc.” (first 2022, latest 2024), across 1 product code in 1 review panel. Median 510(k) review time under this name: 31 days. Since 2017 the median was 31 days, against 170 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2022 | 2 | 58 |
| 2023 | 1 | 194 |
| 2024 | 2 | 30 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Reprise Biomedical, Inc. took a median 31 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 170 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 5 | 5 |
Review panels
Most recent Reprise Biomedical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240753 | Miro3D Fibers Wound Matrix | KGN | 2024-04-19 | 30 |
| K240277 | MiroDry Wound Matrix | KGN | 2024-03-01 | 30 |
| K231614 | MiroTract Wound Matrix | KGN | 2023-12-13 | 194 |
| K223257 | Miro3D Wound Matrix | KGN | 2022-11-21 | 31 |
| K221520 | Miro3D Wound Matrix | KGN | 2022-08-18 | 85 |
Recalls
openFDA lists no recalls under a recalling firm named Reprise Biomedical, 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 Reprise Biomedical, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT06939686: Miro3D Wound Matrix Study for Diabetic Foot Ulcers and Wound Healing (Recruiting, started 2024-11-01)
- NCT06939673: Study of Miro3D Wound Matrix for Healing Wounds and Ulcers in Outpatient Care (Recruiting, started 2024-02-29)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reprise Biomedical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Reprise Biomedical, Inc.” (first 2022, latest 2024), across 1 product code 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 Reprise Biomedical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reprise Biomedical, Inc. is 31 days. Since 2017: 31 days, versus 170 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Reprise Biomedical, Inc.?
The most frequent FDA product codes under this applicant name are KGN (Wound Dressing With Animal-Derived Material(S), 5).
Next steps
- See all 5 Reprise Biomedical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGN, Reprise Biomedical, 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.