510(k) Report

FDA applicant

Yomura Technologies, Inc.

New Taipei City, TW2 decisions2012–20220 recalls

FDA records 2 decisions for Yomura Technologies, Inc. (New Taipei City, TW) from 2012 to 2022: 2 510(k) clearances. Most are in product codes FMG (Stopcock, I.V. Set) and FOZ (Catheter, Intravascular, Therapeutic…). Its devices cite 3 predicates, 0 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, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Yomura Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2012: 12022: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Yomura Technologies, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMGStopcock, I.V. Set1decision
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K210516Clicky CrossYomura Technologies, Inc. · 2022
  • K112542Yomura Safety I.V. CatheterYomura Technologies, Inc. · 2012

All 2 as Yomura Technologies, Inc. →