FDA applicant
Canon, Inc.
FDA records 43 decisions for Canon, Inc. (Kawasaki, JP) from 1994 to 2026: 43 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and HKI (Camera, Ophthalmic, Ac-Powered). Since 2016 its 510(k)s took a median of 28 days from receipt to decision, against 48 for FDA’s reviews in the same codes and years. Its devices cite 58 predicates, 33 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Canon, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
1in 2010
Class I Class II/III not classified
Planning a device like Canon, 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 “Canon”
FDA records each applicant name separately; these may or may not be the same firm.