FDA applicant
Ranfac, Corp.
FDA records 16 decisions for Ranfac, Corp. (Avon, MA) from 1985 to 2023: 16 510(k) clearances. Most are in product codes KNW (Instrument, Biopsy) and MUU (System, Suction, Lipoplasty). Since 2016 its 510(k)s took a median of 91 days from receipt to decision, against 94 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 7 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Ranfac Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ranfac, Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ranfac, Corp.’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