FDA applicant
Kyocera Medical Technologies Inc. (KMTI)
FDA records 3 decisions for Kyocera Medical Technologies Inc. (KMTI) (Redlands, CA) from 2023 to 2026: 3 510(k) clearances. Most are in product codes KWQ (Appliance, Fixation, Spinal Intervertebral Body) and NKB (Thoracolumbosacral Pedicle Screw System). Since 2016 its 510(k)s took a median of 51 days from receipt to decision, against 64 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 0 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. (KMTI)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Kyocera Medical Technologies Inc. (KMTI)’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.