Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alafair Biosciences · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protec | Alafair Biosciences | 2025-07-22 | 67 | 0 |
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Prot | Alafair Biosciences | 2025-07-18 | 49 | 0 |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protec | Alafair Biosciences | 2025-07-17 | 92 | 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