# Alafair Biosciences, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 10 (2016–2025): 10 510(k) clearances
- Names in FDA's records: Alafair Biosciences, Inc. (7); Alafair Biosciences (3)
- Product codes: JXI (4), FTM (3), OWW (3)
- 510(k) review time since 2016: median 81 days, against 81 for FDA's reviews in the same codes and years (5 of 7 faster)
- Predicates its devices cite: 10 (8 its own); citations of its devices by later devices: 9 (8 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Integra LifeSciences Corporation: 2 (https://510kreport.com/company/integra-lifesciences)

## Firms that cite its devices most
- Tybr Health: 1 (https://510kreport.com/company/tybr-health)

## Its most-cited devices
- K232029: VersaWrap Nerve Protector (2023), cited by 2
- K213163: VersaWrap (2021), cited by 2
- K203600: VersaWrap (2021), cited by 1
- K240817: VersaWrap (2024), cited by 1
- K200311: VersaWrap Tendon Protector (2020), cited by 1
- K160364: VersaWrap Tendon Protector (2016), cited by 1

## Recent decisions
- K251505: VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) (Jul 22, 2025)
- K251655: VersaCoat Tendon Protector (VTP-44G2); VersaCoat Tendon Protector (VTP-12G1) (Jul 18, 2025)
- K251175: VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) (Jul 17, 2025)
- K240817: VersaWrap (Jun 14, 2024)
- K232029: VersaWrap Nerve Protector (Nov 2, 2023)
- K213163: VersaWrap (Oct 29, 2021)
- K203600: VersaWrap (Mar 9, 2021)
- K201631: VersaWrap Nerve Protector (Sep 14, 2020)

Source page: https://510kreport.com/company/alafair-biosciences