510(k) Report

FDA applicant

Medexel Co.,Ltd

Anseong-Si, KR3 decisions2016–20240 recalls

FDA records 3 decisions for Medexel Co.,Ltd (Anseong-Si, KR) from 2016 to 2024: 3 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and QNQ (Low Dead Space Piston Syringe). Since 2016 its 510(k)s took a median of 266 days from receipt to decision, against 182 for FDA’s reviews in the same codes and years. 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 Medexel Co.,Ltd’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2016: 12018: 12024: 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 — Medexel 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?

  • FMINeedle, Hypodermic, Single Lumen2decisions
  • QNQLow Dead Space Piston Syringe1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 266 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 182 days; 1 of its 3 were faster than that.

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 2 times; 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.

  • K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd · 20241cites it
  • K172095AutokeeperMedexel Co.,Ltd · 20181cites it

What has FDA decided for it lately?

  • K231856TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534))Medexel Co.,Ltd · 2024
  • K172095AutokeeperMedexel Co.,Ltd · 2018
  • K152410Top Fine Pen NeedleMedexel Co.,Ltd · 2016

All 3 as Medexel Co.,Ltd →

Other applicant names beginning “Medexel”

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

Medexel Medical Mfg. Co., Ltd. 1