510(k) Report

FDA applicant

Sung Shim Medicare Co., Ltd.

Sejing-Si, KR2 decisions2016–20160 recalls

FDA records 2 decisions for Sung Shim Medicare Co., Ltd. (Sejing-Si, KR) in 2016: 2 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). 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, general hospital panel, where it files most

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

FDA decisions per year

2in 2016

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

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

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

Planning a device like Sung Shim Medicare Co., Ltd.’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

Which product codes does it file in?

  • FMFSyringe, Piston1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

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

What has FDA decided for it lately?

  • K152803Sungshim Sterile Single Use Insulin SyringeSung Shim Medicare Co., Ltd. · 2016
  • K152334Sungshim Insulin Pen NeedleSung Shim Medicare Co., Ltd. · 2016

All 2 as Sung Shim Medicare Co., Ltd. →

Other applicant names beginning “Sung”

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

Sung Tai Industrial Co., Ltd. 1Sung Hwan E&B Co.,Ltd 1