Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ventris Medical · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
273 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260596 | Collagen Wound Powder | Ventris Medical | 2026-07-02 | 128 | 0 |
| K250556 | Porous Biologic Scaffold | Ventris Medical | 2025-03-21 | 24 | 0 |
| K240765 | Porous Biologic Scaffold | Ventris Medical | 2024-12-18 | 273 | 0 |
| K240458 | Synthetic Bone Putty | Ventris Medical | 2024-03-07 | 20 | 0 |
| K221644 | Synthetic Bone Putty | Ventris Medical | 2022-09-02 | 88 | 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