FDA applicant
Ronpak, Inc.
FDA records 1 decision for Ronpak, Inc. (South Plainfield, NJ) in 2003: 1 510(k) clearance. All are in product code FRG (Wrap, Sterilization). 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 Ronpak, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Ronpak, Inc. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ronpak, 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