510(k) Report

FDA applicant

Shenzhen Belter Health Measurement and Analysis TE

Shenzhen, Guangdong, CN3 decisions2013–20140 recalls

FDA records 3 decisions for Shenzhen Belter Health Measurement and Analysis TE (Shenzhen, Guangdong, CN) from 2013 to 2014: 3 510(k) clearances. Most are in product codes MNW (Analyzer, Body Composition) and DXN (System, Measurement, Blood-Pressure…). 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, cardiovascular panel, where it files most

How often FDA has decided Shenzhen Belter Health Measurement and Analysis TE’s devices, and how often a recall has named them.

FDA decisions per year

2in 2014

2013: 12014: 2
2013high 2 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Shenzhen Belter Health Measurement and Analysis TE by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MNWAnalyzer, Body Composition1decision
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive1decision
  • FLLContinuous Measurement Thermometer1decision

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.

  • K140681Belter Infra-Red Ear ThermometerShenzhen Belter Health Measurement and Analysis TE · 20141cites it

What has FDA decided for it lately?

  • K140681Belter Infra-Red Ear ThermometerShenzhen Belter Health Measurement and Analysis TE · 2014
  • K134029Belter Blood Pressure MeterShenzhen Belter Health Measurement and Analysis TE · 2014
  • K122976Body Fat Scale Model SF-371Shenzhen Belter Health Measurement and Analysis TE · 2013

All 3 as Shenzhen Belter Health Measurement and Analysis TE →