Ventris Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ventris Medical” (first 2022, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 88 days. Since 2017 the median was 88 days, against 119 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 | 1 | 88 |
| 2023 | 0 | — |
| 2024 | 2 | 146 |
| 2025 | 1 | 24 |
| 2026 | 1 | 128 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ventris Medical took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 4 | 4 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 | 1 |
Review panels
Most recent Ventris Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260596 | Collagen Wound Powder | KGN | 2026-07-02 | 128 |
| K250556 | Porous Biologic Scaffold | MQV | 2025-03-21 | 24 |
| K240765 | Porous Biologic Scaffold | MQV | 2024-12-18 | 273 |
| K240458 | Synthetic Bone Putty | MQV | 2024-03-07 | 20 |
| K221644 | Synthetic Bone Putty | MQV | 2022-09-02 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Ventris Medical.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ventris Medical?
FDA lists 5 510(k) clearances under the applicant name “Ventris Medical” (first 2022, latest 2026), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ventris Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ventris Medical is 88 days. Since 2017: 88 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ventris Medical?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 4); KGN (Wound Dressing With Animal-Derived Material(S), 1).
Next steps
- See all 5 Ventris Medical clearances with predicates and recalls
- Run predicate analysis for product code MQV, Ventris Medical'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.