FDA applicant
Hanuri Distribution, Inc.
FDA records 2 decisions for Hanuri Distribution, Inc. (Chatsworth, CA) from 2011 to 2020: 2 510(k) clearances. Most are in product codes IRP (Massager, Powered Inflatable Tube) and JOW (Sleeve, Limb, Compressible). Its devices cite 2 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 Hanuri Distribution, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2020
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Hanuri Distribution, 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