Bionova Medical, Inc.: FDA clearances and approvals
Bionova Medical, Inc. has 6 FDA 510(k) clearances (first 2012, latest 2024), across 2 product codes in 1 review panel. Median 510(k) review time: 169 days. Since 2017 its median was 169 days, against 203 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 312 |
| 2013 | 1 | 100 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 499 |
| 2023 | 1 | 136 |
| 2024 | 2 | 116 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Bionova Medical, Inc.'s cleared 510(k)s took a median 169 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 203 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KGN | Wound Dressing With Animal-Derived Material(S) | 4 | 4 |
| FRO | Dressing, Wound, Drug | 2 | 2 |
Review panels
Most recent Bionova Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | FRO | 2024-10-31 | 31 |
| K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | FRO | 2024-08-21 | 202 |
| K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | KGN | 2023-11-13 | 136 |
| K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | KGN | 2022-08-11 | 499 |
| K123961 | SENTREX BIOSPONGE MPD | KGN | 2013-04-05 | 100 |
| K112191 | HEALEX BIOSPONGE WOUND DRESSING | KGN | 2012-06-05 | 312 |
Recalls
openFDA lists no recalls under a recalling firm named Bionova Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bionova Medical, Inc. have?
Bionova Medical, Inc. has 6 FDA 510(k) clearances (first 2012, latest 2024), across 2 product codes in 1 review panel.
How long does FDA take to clear Bionova Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Bionova Medical, Inc.'s cleared 510(k)s is 169 days. Since 2017: 169 days, versus 203 days for all cleared 510(k)s in the same product codes.
What devices does Bionova Medical, Inc. make?
Its most frequent FDA product codes are KGN (Wound Dressing With Animal-Derived Material(S), 4); FRO (Dressing, Wound, Drug, 2).
Has Bionova Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bionova Medical, Inc. Related entities may recall under other names.
Next steps
- See all 6 Bionova Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGN, Bionova Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.