FDA applicant
Nihon Kohden Corporation
FDA records 31 decisions for Nihon Kohden Corporation (Tokyo, JP) from 2010 to 2026: 31 510(k) clearances. Most are in product codes CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase) and MHX (Monitor, Physiological, Patient (With…). Since 2016 its 510(k)s took a median of 184 days from receipt to decision, against 178 for FDA’s reviews in the same codes and years. Its devices cite 55 predicates, 7 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Nihon Kohden Corp.”, “Nihon Kohden”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nihon Kohden Corporation’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
1in 2026
Class I Class II/III not classified
Planning a device like Nihon Kohden Corporation’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.