510(k) Report

FDA applicant

Intelesens Limited

Bonita Springs, FL4 decisions2011–20160 recalls

FDA records 4 decisions for Intelesens Limited (Bonita Springs, FL) from 2011 to 2016: 4 510(k) clearances. Most are in product codes MHX (Monitor, Physiological, Patient (With…) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Intelesens, Ltd.”.

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 Intelesens Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2011: 12014: 12015: 12016: 1
2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Intelesens Limited by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MHXMonitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)3decisions
  • DSIDetector And Alarm, Arrhythmia1decision

Whose devices does it build on?

Its devices cite 7 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 20113cite it

What has FDA decided for it lately?

  • K153275Aingeal Activity SystemIntelesens, Ltd. · 2016
  • K151027zensor systemIntelesens Limited · 2015
  • K131000V-Patch SystemIntelesens Limited · 2014
  • K110015Vitalsens, Aingeal, V-PodIntelesens Limited · 2011

All 3 as Intelesens Limited →The one decision as Intelesens, Ltd. →