FDA applicant
Ito Co., Ltd.
FDA records 8 decisions for Ito Co., Ltd. (Rockville, MD) from 1999 to 2021: 8 510(k) clearances. Most are in product codes ITH (Equipment, Traction, Powered) and IMI (Ultrasonic Diathermy For Use In Applying…). Its devices cite 12 predicates, 2 of them its own earlier devices. 1 recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Ito Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Ito Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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