Alafair Biosciences, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Alafair Biosciences, Inc.” (first 2016, latest 2025), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 86 days. Since 2017 the median was 81 days, against 107 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2016 | 1 | 122 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 60 |
| 2021 | 2 | 60 |
| 2022 | 0 | — |
| 2023 | 1 | 118 |
| 2024 | 1 | 81 |
| 2025 | 3 | 67 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Alafair Biosciences, Inc. took a median 81 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXI | Cuff, Nerve | 4 | 4 |
| FTM | Mesh, Surgical | 3 | 3 |
| OWW | Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon | 3 | 3 |
Review panels
- Neurology (4)
- Orthopedic (3)
- General and Plastic Surgery (3)
Most recent Alafair Biosciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | JXI | 2025-07-22 | 67 |
| K251655 | VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) | OWW | 2025-07-18 | 49 |
| K251175 | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | JXI | 2025-07-17 | 92 |
| K240817 | VersaWrap | OWW | 2024-06-14 | 81 |
| K232029 | VersaWrap Nerve Protector | JXI | 2023-11-02 | 118 |
| K213163 | VersaWrap | FTM | 2021-10-29 | 31 |
| K203600 | VersaWrap | FTM | 2021-03-09 | 90 |
| K201631 | VersaWrap Nerve Protector | JXI | 2020-09-14 | 90 |
| K200311 | VersaWrap Tendon Protector | FTM | 2020-03-06 | 29 |
| K160364 | VersaWrap Tendon Protector | OWW | 2016-06-10 | 122 |
Recalls
openFDA lists no recalls under a recalling firm named Alafair Biosciences, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Alafair Biosciences, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Alafair Biosciences, Inc.” (first 2016, latest 2025), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Alafair Biosciences, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Alafair Biosciences, Inc. is 86 days. Since 2017: 81 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Alafair Biosciences, Inc.?
The most frequent FDA product codes under this applicant name are JXI (Cuff, Nerve, 4); FTM (Mesh, Surgical, 3); OWW (Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon, 3).
Next steps
- See all 10 Alafair Biosciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JXI, Alafair Biosciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.