# K110015: Vitalsens, Aingeal, V-Pod

- Pathway: 510(k) (Traditional)
- Applicant: Intelesens Limited
- Decided: May 20, 2011 after 137 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: 8 generations back to K962603 (1997). 43 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 48 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071805: Netguard Automated Clinician Alert System, Model 0998-00-1600-XX, Datascope Corp. (2007) Summary page 1.
- K093976: Raisin Personal  Monitor, Proteus Biomedical, Inc. (2010) Summary page 1.
- K083185: Cadi Smartsense Vital Signs and Wireless Temperature Monitori NG System, Model S1, Cadi Scientific Pte.Ltd (2009) Summary page 1.
- K033378: Vital Signs Monitor, Propaq LT, Welch Allyn Protocol, Inc. (2004) Summary page 1.

## Most influential descendants
- K132407: Vital Signs Patch System (in Short VSP) (2014), 1 descendant of its own
- K153275: Aingeal Activity System (2016), 0 descendants of its own
- K151835: Vital Signs Patch System (2016), 0 descendants of its own
- K151027: zensor system (2015), 0 descendants of its own

## Indications for use
The intelesens Vital Signs Monitor Aingeal (VS200) is used to mnonitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is intended to be used on the patient for short termi periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting. The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useflul. The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmnia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmnia event.

Source page: https://510kreport.com/device/K110015
Methodology: https://510kreport.com/methodology