FDA applicant
Merchsource, LLC
FDA records 3 decisions for Merchsource, LLC (Irvine, CA) in 2025: 3 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and IRP (Massager, Powered Inflatable Tube). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 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 Merchsource, LLC’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 2025.
Planning a device like Merchsource, 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) Report