510(k) Report

FDA applicant

Medirune Co, Ltd.

Gangnam-Gu, KR1 decision2013–20130 recalls

FDA records 1 decision for Medirune Co, Ltd. (Gangnam-Gu, KR) in 2013: 1 510(k) clearance. All are in product code NUH (Stimulator, Nerve, Transcutaneous…). Its devices cite 1 predicate, 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, neurology panel, where it files most

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

FDA decisions per year

1in 2013

2013: 1
2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

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

Planning a device like Medirune 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?

  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K122410I Rune (I-200L)Medirune Co, Ltd. · 2013

The one decision as Medirune Co, Ltd. →