# K974510: Envoy Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Inc.
- Decided: Apr 14, 1998 after 134 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: 1 generation back to K911616 (1991). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911616: Horizon XL, Mennen Medical, Inc. (1991) Summary page 1.
- K941811: HP M1175A, M1176A, Component Monitoring System, Hewlett-Packard Co. (1994) Summary page 1.

## Most influential descendants
- K982697: Modification to Ensemble Central Station Monitor (1998), 0 descendants of its own

## Indications for use
The ENVOY Monitor is a physiological patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment, such as: ECG/Heart Rate, Invasive Blood Pressure, Respiration, Temperature, Noninvasive Blood Pressure, and Pulse Oximetry. The ENVOY may be used to monitor a wide range of patient conditions in many different clinical specialties within the hospital. The device is intended for use by qualified health care providers, who will determine when use of the device is indicated, based upon their professional assessment of the patient’s medical condition.

Source page: https://510kreport.com/device/K974510
Methodology: https://510kreport.com/methodology