FDA applicant
Kane Biotech, Inc.
FDA records 3 decisions for Kane Biotech, Inc. (Winnipeg, CA) from 2023 to 2026: 3 510(k) clearances. All are in product code FRO (Dressing, Wound, Drug). Since 2016 its 510(k)s took a median of 132 days from receipt to decision, against 263 for FDA’s reviews in the same codes and years. Its devices cite 5 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kane Biotech, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Kane Biotech, 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