# K151835: Vital Signs Patch System

- Pathway: 510(k) (Special)
- Applicant: Lifewatch Technologies, Ltd.
- Decided: Feb 5, 2016 after 214 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 10 generations back to K962603 (1997). 51 ancestors in all.
No later device cites it as a predicate yet.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132407: Vital Signs Patch System (in Short VSP), Lifewatch Technologies, Ltd. (2014) Summary page 5.

## Indications for use
The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional. Contraindications: • The VSP is not intended for use by persons with any type of defibrillator, external or internal (ICD); the VSP must be detached from the patient before using a defibrillator on the patient • The VSP is not to be used in a magnetic resonance imaging (MRI) environment. The VSP device must be removed from the patient’s skin before he/she undergoes MRI procedure • The VSP is not a “life-saving” or therapeutic device; the VSP supplies vital signs data to a doctor or technician for the purpose of diagnosis by such (or other qualified) personnel • The VSP is not intended for use on patients with unhealed surgical incision/dressings on the thoracic or abdominal regions • The VSP is not intended for use on patients with skin or soft tissue damage on the area where the VSP is placed (such as burns, irritation, infections, wounds, etc.) • The VSP is not intended for use in the diagnosis of myocardial infarction or for chest pain monitoring. Warning: The temperature function of the Vital Signs Patch measures and reports surface temperature on the upper chest. Where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.

Source page: https://510kreport.com/device/K151835
Methodology: https://510kreport.com/methodology