510(k) Report

FDA applicant

Daejin Tech Medical Manufacturing Co., Ltd.

Deer Field, IL2 decisions2007–20070 recalls

FDA records 2 decisions for Daejin Tech Medical Manufacturing Co., Ltd. (Deer Field, IL) in 2007: 2 510(k) clearances. Most are in product codes FMF (Syringe, Piston) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 4 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 Daejin Tech Medical Manufacturing Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2007

2007: 2
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Daejin Tech Medical Manufacturing Co., Ltd. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston1decision
  • FMINeedle, Hypodermic, Single Lumen1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 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.

  • K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 20072cite it
  • K063348Top Fine Insulin SyringeDaejin Tech Medical Manufacturing Co., Ltd. · 20071cites it

What has FDA decided for it lately?

  • K063466Top FineDaejin Tech Medical Manufacturing Co., Ltd. · 2007
  • K063348Top Fine Insulin SyringeDaejin Tech Medical Manufacturing Co., Ltd. · 2007

All 2 as Daejin Tech Medical Manufacturing Co., Ltd. →