510(k) Report

FDA applicant

Idt Technology Limited

Kowloon, HK6 decisions2002–20150 recalls

FDA records 6 decisions for Idt Technology Limited (Kowloon, HK) from 2002 to 2015: 6 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and FLL (Continuous Measurement Thermometer). Its devices cite 1 predicate, 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 Idt Technology Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2014: 12015: 1
2007high 1 (2014) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Idt Technology Limited 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-Invasive4decisions
  • FLLContinuous Measurement Thermometer1decision
  • MNWAnalyzer, Body Composition1decision

Whose devices does it build on?

Its devices cite 1 predicate; 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.

  • K050083Blood-Pressure Meter, BPW120Idt Technology Limited · 20051cites it
  • K020433FT101 Forehead Thermometer; FT101 Infrared Digital ThermometerIdt Technology Limited · 20021cites it

What has FDA decided for it lately?

  • K151415Oregon ScientificIdt Technology Limited · 2015
  • K131245Oregon ScintificIdt Technology Limited · 2014
  • K050083Blood-Pressure Meter, BPW120Idt Technology Limited · 2005
  • K031167High Precision Body Weight Monitor with Body Fat IndexIdt Technology Limited · 2004
  • K020433FT101 Forehead Thermometer; FT101 Infrared Digital ThermometerIdt Technology Limited · 2002
  • K021252Blood-Pressure MeterIdt Technology Limited · 2002

All 6 as Idt Technology Limited →