510(k) Report

FDA applicant

Nien Made Electrnics Corp.

Concord, MA2 decisions2000–20010 recalls

FDA records 2 decisions for Nien Made Electrnics Corp. (Concord, MA) from 2000 to 2001: 2 510(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 Nien Made Electrnics Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nien Made Electrnics Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nien Made Electrnics Corp. 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-Invasive1decision
  • FLLContinuous Measurement Thermometer1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K011310Nien Made Non-Invasive Blood Pressure Monitor, Models HP-BPM0001; HP-BPM0002; HP-BPM0003; HP-BPM0003-1Nien Made Electrnics Corp. · 2001
  • K993950Cecilia Penguin Multi-Use Thermometer, Model HP-ETO9999Nien Made Electrnics Corp. · 2000

All 2 as Nien Made Electrnics Corp. →