Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Alafair Biosciences, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
122 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240817 | VersaWrap | Alafair Biosciences, Inc. | 2024-06-14 | 81 | 0 |
| K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2023-11-02 | 118 | 0 |
| K213163 | VersaWrap | Alafair Biosciences, Inc. | 2021-10-29 | 31 | 0 |
| K203600 | VersaWrap | Alafair Biosciences, Inc. | 2021-03-09 | 90 | 0 |
| K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2020-09-14 | 90 | 0 |
| K200311 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2020-03-06 | 29 | 0 |
| K160364 | VersaWrap Tendon Protector | Alafair Biosciences, Inc. | 2016-06-10 | 122 | 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