FDA applicant
Totoku Electric Co., Ltd.
FDA records 40 decisions for Totoku Electric Co., Ltd. (Ueda, JP) from 2001 to 2011: 40 510(k) clearances. All are in product code LLZ (System, Image Processing, Radiological). Its devices cite 40 predicates, 36 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 Totoku Electric Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
5in 2011
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Totoku Electric 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