FDA applicant
Konica Minolta, Inc.
FDA records 25 decisions for Konica Minolta, Inc. (Hino-Shi, JP) from 2014 to 2025: 25 510(k) clearances. Most are in product codes MQB (Solid State X-Ray Imager (Flat Panel/Digital…) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 77 days from receipt to decision, against 56 for FDA’s reviews in the same codes and years. Its devices cite 34 predicates, 20 of them its own earlier devices. 7 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Konica Minolta, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Konica Minolta, 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 “Konica”
FDA records each applicant name separately; these may or may not be the same firm.