FDA applicant
Varian Medical Systems, Inc.
FDA records 206 decisions for Varian Medical Systems, Inc. (Palo Alto, CA) from 1997 to 2026: 206 510(k) clearances. Most are in product codes IYE (Accelerator, Linear, Medical) and JAQ (System, Applicator, Radionuclide…). Since 2016 its 510(k)s took a median of 99 days from receipt to decision, against 126 for FDA’s reviews in the same codes and years. Its devices cite 258 predicates, 168 of them its own earlier devices. 119 recalls are linked to its devices.
FDA’s records also spell it “Varian Medical Systems”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Varian Medical Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
10in 2025
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Varian Medical Systems, 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) ReportOther applicant names beginning “Varian”
FDA records each applicant name separately; these may or may not be the same firm.