# K020632: Enguard Remote Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Mennen Medical, Ltd.
- Decided: Mar 15, 2002 after 16 days
- Product code: QYX (Outpatient Cardiac Telemetry)
- 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: 1 generation back to K001120 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001120: Envoy Patient Monitor, Mennen Medical, Ltd. (2001) Summary page 6.

## Indications for use
Enguard is intended for use as a remote patient multiparameter monitoring system. The Enguard can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure and EtCO2. This effectively allows the Enguard to monitor & wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multiparameter waveforms, vital signs, alarm & status messages. The Mennen Medical Enguard is intended for sale as a system for remote monitoring and recording patient information or any in-hospital application requiring remote patient monitoring. The following are examples of intended clinical applications: Critical Care Patients Cardiac Step-down/Telemetry Units Emergency Departments Intra-operative (Anesthesia) Monitoring Post Anesthesia Care

Source page: https://510kreport.com/device/K020632
Methodology: https://510kreport.com/methodology