FDA applicant
Mentor Worldwide, LLC
FDA records 14 decisions for Mentor Worldwide, LLC (Irvine, CA) from 2000 to 2025: 12 510(k) clearances and 2 original PMA approvals. Most are in product codes LCJ (Tissue Expander And Accessories) and MRD (Mammary Sizer). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 153 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 11 of them its own earlier devices. 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Mentor Worldwide, LLC’s devices, and how often a recall has named them.
FDA decisions per year
3in 2025
2026 so far, outlined.
Recalls per year
6in 2026
Class I Class II/III not classified
Planning a device like Mentor Worldwide, LLC’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) ReportOther applicant names beginning “Mentor”
FDA records each applicant name separately; these may or may not be the same firm.