FDA applicant
Palette Life Sciences
FDA records 3 decisions for Palette Life Sciences (Santa Barbara) from 2001 to 2022: 1 510(k) clearance and 2 original PMA approvals. Most are in product codes LNM (Agent, Bulking, Injectable For Gastro-Urology…) and OVB (Hydrogel Spacer). Its devices cite 1 predicate, 0 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 Palette Life Sciences’s devices, and how often a recall has named them.
FDA decisions per year
1in 2022
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Palette Life Sciences’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