510(k) Report

FDA applicant

Zen Strong Medical Technology Co., Ltd.

Keelung,, TW3 decisions2007–20090 recalls

FDA records 3 decisions for Zen Strong Medical Technology Co., Ltd. (Keelung,, TW) from 2007 to 2009: 3 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Its devices cite 5 predicates, 1 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, cardiovascular panel, where it files most

How often FDA has decided Zen Strong Medical Technology Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2007: 22009: 1
2007high 2 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Zen Strong Medical Technology 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?

  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive2decisions
  • FLLContinuous Measurement Thermometer1decision

Whose devices does it build on?

Its devices cite 5 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 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.

  • K070473Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd. · 20072cite it

What has FDA decided for it lately?

  • K090027Blood Pressure Monitor, ZSBP-003/004/005/006/007/008 and ZSBP-102/103/104/105/106/107Zen Strong Medical Technology Co., Ltd. · 2009
  • K070578Clinical Thermometer/Model ZSDT-XXXX Digital Thermometer and Zset-XXX Infrared ThermometerZen Strong Medical Technology Co., Ltd. · 2007
  • K070473Blood Pressure Monitor, Models ZSBP-Oxx and ZSBP-1XXZen Strong Medical Technology Co., Ltd. · 2007

All 3 as Zen Strong Medical Technology Co., Ltd. →