510(k) Report

FDA applicant

Eutectic Electronics, Inc.

Raleigh, NC2 decisions1985–19890 recalls

FDA records 2 decisions for Eutectic Electronics, Inc. (Raleigh, NC) from 1985 to 1989: 2 510(k) clearances. Most are in product codes DXN (System, Measurement, Blood-Pressure…) and EXY (Uroflowmeter). 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 Eutectic Electronics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eutectic Electronics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Eutectic Electronics, Inc. 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
  • EXYUroflowmeter1decision

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.

  • K894968UltracompactEutectic Electronics, Inc. · 19891cites it

What has FDA decided for it lately?

  • K894968UltracompactEutectic Electronics, Inc. · 1989
  • K850867Accutracker Heart-Rate MonitorEutectic Electronics, Inc. · 1985

All 2 as Eutectic Electronics, Inc. →