FDA applicant

Tomy International

Canton, MA2 decisions2013–20260 recalls

FDA records 2 decisions for Tomy International (Canton, MA) from 2013 to 2026: 2 510(k) clearances. All are in product code HGX (Pump, Breast, Powered). No recall is linked to its devices.

FDA’s records also spell it “Tomy International, Inc.”.

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 Tomy International’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Tomy International by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tomy International’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

Other applicant names beginning “Tomy”

FDA records each applicant name separately; these may or may not be the same firm.

Tomy, Inc. 4

Tomy International

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Tomy”