Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bionova Medical, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
202 daysmedian FDA review time
499 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | 2024-10-31 | 31 | 0 |
| K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024-08-21 | 202 | 0 |
| K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023-11-13 | 136 | 0 |
| K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2022-08-11 | 499 | 0 |
| K123961 | SENTREX BIOSPONGE MPD | Bionova Medical, Inc. | 2013-04-05 | 100 | 0 |
| K112191 | HEALEX BIOSPONGE WOUND DRESSING | Bionova Medical, Inc. | 2012-06-05 | 312 | 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