FDA applicant
Riken Keiki Co., Ltd.
FDA records 1 decision for Riken Keiki Co., Ltd. (Wales Center, NY) in 1995: 1 510(k) clearance. All are in product code CBS (Analyzer, Gas, Halothane, Gaseous-Phase…). 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 Riken Keiki Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Riken Keiki Co., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Riken Keiki Co., Ltd.’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) Report