510(k) Report

FDA applicant

Tokai Hit Co., Ltd.

Fujinomiya-Shi, Shizuoka-Ken, JP1 decision1999–19990 recalls

FDA records 1 decision for Tokai Hit Co., Ltd. (Fujinomiya-Shi, Shizuoka-Ken, JP) in 1999: 1 510(k) clearance. All are in product code MQG (Accessory, Assisted Reproduction). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, obstetrics and gynecology panel, where it files most

How often FDA has decided Tokai Hit Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tokai Hit Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tokai Hit Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tokai Hit 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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Which product codes does it file in?

  • MQGAccessory, Assisted Reproduction1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K991263ThermoplateTokai Hit Co., Ltd. · 19991cites it

What has FDA decided for it lately?

  • K991263ThermoplateTokai Hit Co., Ltd. · 1999

The one decision as Tokai Hit Co., Ltd. →