510(k) Report

FDA applicant

Shina Med Corporation

Anseong-Si, KR7 decisions2016–20251 recall

FDA records 7 decisions for Shina Med Corporation (Anseong-Si, KR) from 2016 to 2025: 7 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). Since 2016 its 510(k)s took a median of 236 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 8 predicates, 4 of them its own earlier devices. 1 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 Shina Med Corporation’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2016: 22019: 12022: 12023: 12025: 2
2016high 2 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

1in 2018

2018: 1
2016high 1 (2018) · low 0 (2016)2026

Class I Class II/III not classified

FIG. 1 — Shina Med Corporation by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Shina Med Corporation’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?

  • FMFSyringe, Piston4decisions
  • FMINeedle, Hypodermic, Single Lumen2decisions
  • MEGSyringe, Antistick1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 236 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 3 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 8 predicates; 4 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.

  • K152879Sure-Fine Insulin SyringesShina Med Corporation · 20161cites it
  • K191531Sure-Fine Insulin SyringesShina Med Corporation · 20191cites it
  • K210848Sure-Fine Insulin SyringesShina Med Corporation · 20221cites it
  • K152877SureFine Pen NeedleShina Med Corporation · 20161cites it

What has FDA decided for it lately?

  • K250510Sure-Fine Insulin SyringesShina Med Corporation · 2025
  • K250658SureFine Pen NeedleShina Med Corporation · 2025
  • K231165Shina Syringe; Shina Safety SyringeShina Med Corporation · 2023
  • K210848Sure-Fine Insulin SyringesShina Med Corporation · 2022
  • K191531Sure-Fine Insulin SyringesShina Med Corporation · 20191 recall
  • K152879Sure-Fine Insulin SyringesShina Med Corporation · 2016
  • K152877SureFine Pen NeedleShina Med Corporation · 2016

All 7 as Shina Med Corporation →

What has been recalled?

1 recall linked to its devices; the latest:

  • K191531InControl Insulin Syringes, Short Needle, 29 Gauge, 1CCJan 19, 2018Class II

Other applicant names beginning “Shina”

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

Shina Systems, Ltd. 4Shina Corp. 4