510(k) Report

FDA applicant

Jeesung Medical Co., Ltd.

Daejeon, KR3 decisions2016–20220 recalls

FDA records 3 decisions for Jeesung Medical Co., Ltd. (Daejeon, KR) from 2016 to 2022: 3 510(k) clearances. Most are in product codes MEG (Syringe, Antistick) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 342 days from receipt to decision, against 216 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 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 Jeesung Medical Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2016: 22022: 1
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Jeesung Medical 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?

  • MEGSyringe, Antistick2decisions
  • FMINeedle, Hypodermic, Single Lumen1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 342 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 216 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 20161cites it

What has FDA decided for it lately?

  • K212518Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2022
  • K152166JSM Insulin Pen NeedleJeesung Medical Co., Ltd. · 2016
  • K152606Jeesung Safety Syringe and Single Use NeedlesJeesung Medical Co., Ltd. · 2016

All 3 as Jeesung Medical Co., Ltd. →