510(k) Report

FDA applicant

Thinkmed Medical Technology Co., Ltd.

Kunshan, CN2 decisions2015–20150 recalls

FDA records 2 decisions for Thinkmed Medical Technology Co., Ltd. (Kunshan, CN) in 2015: 2 510(k) clearances. Most are in product codes FMI (Needle, Hypodermic, Single Lumen) and GBM (Catheter, Urethral). Its devices cite 3 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 Thinkmed Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2015: 2
2015high 2 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Thinkmed Medical Technology Co., Ltd. by year, 2015–2026Sources: 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 Lumen1decision
  • GBMCatheter, Urethral1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K142765TM Safety NeedleThinkmed Medical Technology Co., Ltd. · 20151cites it

What has FDA decided for it lately?

  • K142765TM Safety NeedleThinkmed Medical Technology Co., Ltd. · 2015
  • K142767ThinkMed Intermittent Catheter with/without Hydrophilic CoatingThinkmed Medical Technology Co., Ltd. · 2015

All 2 as Thinkmed Medical Technology Co., Ltd. →