FDA applicant
Alafair Biosciences, Inc.
FDA records 10 decisions for Alafair Biosciences, Inc. (Austin, TX) from 2016 to 2025: 10 510(k) clearances. Most are in product codes JXI (Cuff, Nerve) and FTM (Mesh, Surgical). Since 2016 its 510(k)s took a median of 81 days from receipt to decision, against 81 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 8 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Alafair Biosciences”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alafair Biosciences, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2016.
Planning a device like Alafair Biosciences, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report