510(k) Report

FDA applicant

Nexan, Ltd.

Rockville, MD2 decisions2000–20010 recalls

FDA records 2 decisions for Nexan, Ltd. (Rockville, MD) from 2000 to 2001: 2 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and MWJ (Electrocardiograph, Ambulatory (Without…). 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 Nexan, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Nexan, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Nexan, 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?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)1decision
  • MWJElectrocardiograph, Ambulatory (Without Analysis)1decision

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.

  • K003520Nexan System, Model NX-300Nexan, Ltd. · 20002cite it

What has FDA decided for it lately?

  • K010424Nexan System, Model NX-301Nexan, Ltd. · 2001
  • K003520Nexan System, Model NX-300Nexan, Ltd. · 2000

All 2 as Nexan, Ltd. →

Other applicant names beginning “Nexan”

FDA records each applicant name separately; these may or may not be the same firm.

Nexan Telemed, Ltd. 1