Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OXH · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
90 daysmedian FDA review time
250 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251844 | Kerecis SurgiBind (50241) | Kerecis Limited | 2025-07-15 | 29 | 0 |
| K202430 | Kerecis Reconstruct | Kerecis Limited | 2021-05-02 | 250 | 0 |
| K171357 | SurgiMend PRS Meshed, Revize-X | Integra Lifesciences Corporation (Owner of Tei Biosciences) | 2017-06-07 | 29 | 2 |
| K160400 | Miromatrix Biological Mesh | Miromatrix Medical, Inc. | 2016-06-08 | 117 | 0 |
| K150341 | Miromatrix Biological Mesh RS | Miromatrix Medical, Inc. | 2015-05-12 | 90 | 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