510(k) Report

FDA applicant

Daehan Medical Systems Co., Ltd.

Siheung-City, KR3 decisions2016–20190 recalls

FDA records 3 decisions for Daehan Medical Systems Co., Ltd. (Siheung-City, KR) from 2016 to 2019: 3 510(k) clearances. Most are in product codes GXY (Electrode, Cutaneous) and GXZ (Electrode, Needle). Its devices cite 2 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, neurology panel, where it files most

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

FDA decisions per year

1in 2019

2016: 12018: 12019: 1
2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Daehan Medical Systems Co., Ltd. by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • GXYElectrode, Cutaneous2decisions
  • GXZElectrode, Needle1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

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.

  • K180232DAEHAN Disposable CUP ElectrodesDaehan Medical Systems Co., Ltd. · 20191cites it

What has FDA decided for it lately?

  • K180232DAEHAN Disposable CUP ElectrodesDaehan Medical Systems Co., Ltd. · 2019
  • K180247DAEHAN Adhesive Surface ElectrodesDaehan Medical Systems Co., Ltd. · 2018
  • K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. · 2016

All 3 as Daehan Medical Systems Co., Ltd. →