FDA applicant
Kyocera Medical Technologies, Inc.
FDA records 16 decisions for Kyocera Medical Technologies, Inc. (Redlands, CA) from 2020 to 2026: 16 510(k) clearances. Most are in product codes OVD (Intervertebral Fusion Device With Integrated…) and OQG (Hip Prosthesis, Semi-Constrained, Cemented…). Since 2016 its 510(k)s took a median of 85 days from receipt to decision, against 99 for FDA’s reviews in the same codes and years. Its devices cite 45 predicates, 6 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Kyocera Medical Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
4in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2020.
Planning a device like Kyocera Medical Technologies, 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 “Kyocera”
FDA records each applicant name separately; these may or may not be the same firm.