FDA applicant
Richard Wolf Medical Instruments Corp.
FDA records 155 decisions for Richard Wolf Medical Instruments Corp. (Vernon Hills, IL) from 1977 to 2024: 153 510(k) clearances and 2 original PMA approvals. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HRX (Arthroscope). Since 2016 its 510(k)s took a median of 115 days from receipt to decision, against 106 for FDA’s reviews in the same codes and years. Its devices cite 126 predicates, 80 of them its own earlier devices. 16 recalls are linked to its devices.
FDA’s records also spell it “Richard Wolf Medical Instruments Corporation”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Richard Wolf Medical Instruments Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
2in 2023
Class I Class II/III not classified
Planning a device like Richard Wolf Medical Instruments 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) ReportOther applicant names beginning “Richard”
FDA records each applicant name separately; these may or may not be the same firm.