# K151027: zensor system

- Pathway: 510(k) (Traditional)
- Applicant: Intelesens Limited
- Decided: Oct 2, 2015 after 168 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962603 (1997). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110015: Vitalsens, Aingeal, V-Pod, Intelesens Limited (2011) Summary page 4.

## Indications for use
The zensor monitoring device is a small, lightweight, wearable, non-invasive, re-chargeable battery operated system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient’s body. The device is to be used in the home environment to provide clinicians with patient physiological data. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The zensor monitoring system displays ECG and respiration waveforms from the zensor monitoring device. The system monitors the following configurable physiological parameters: Heart Rate and Respiration Rate, as well as key cardiac arrhythmias, and a patient activated recording. The zensor monitoring system has the option to store full disclosure ECG, Respiration and accelerometer data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronline system for review by healthcare practitioners. All physiological data stored on the device can be imported for viewing on Intelesens zensor+ (Ambulatory Full Disclosure ECG and Event Viewer) for later analysis by a clinician.

Source page: https://510kreport.com/device/K151027
Methodology: https://510kreport.com/methodology