FDA applicant
Nihon Kohden America, Inc.
FDA records 166 decisions for Nihon Kohden America, Inc. (Irvine, CA) from 1979 to 2012: 166 510(k) clearances. Most are in product codes DPS (Electrocardiograph) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 62 predicates, 47 of them its own earlier devices. 4 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Nihon Kohden America, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2012
2026 so far, outlined.
Recalls per year
1in 2021
Class I Class II/III not classified
Planning a device like Nihon Kohden America, 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”
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