FDA applicant
Nihon Kohden Orangemed, Inc.
FDA records 5 decisions for Nihon Kohden Orangemed, Inc. (Santa Ana, CA) from 2018 to 2024: 5 510(k) clearances. Most are in product codes CBK (Ventilator, Continuous, Facility Use) and MNT (Continuous, Minimal Ventilatory Support…). Since 2016 its 510(k)s took a median of 211 days from receipt to decision, against 193 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 3 of them its own earlier devices. 1 recall is linked to its devices.
FDA’s records also spell it “Nihon Kohden Orangemed, LLC”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nihon Kohden Orangemed, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Nihon Kohden Orangemed, 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 “Nihon”
FDA records each applicant name separately; these may or may not be the same firm.