# K024245: Envoy Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: May 10, 2004 after 504 days
- Product code: OMC (Reduced- Montage Standard Electroencephalograph)
- Device class: 2
- Regulation: 21 CFR 882.1400
- 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 K910945 (1991). 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)
- K910945: Horizon 2000 Eeg Monitoring Option, Mennen Medical, Inc. (1991) Summary page 2.

## Indications for use
The Envoy s intended for use as a multiparameter monitoring system. The Envoy can monitor ECG/heart rate, two invasive blood pressure channels, two temperature channels, pulse oximetry, respiration, non-invasive blood pressure, E{CO2 and EEG, The EEG module is not intended for use on infants. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, In many different areas of the hospital. Functions include display of multiparameter waveforms, vital slgns, alarm & status messages. The Mennen Medical Envoy is intended for sale as a system for monitoring and recording patient information or any in-hospital application requiring patient monitoring. The following.are examples of intended clinical applications: « Critical Care Patients o Cardiac Step-down/Telemetry Units + Emergency Departments « Intra-operative (Anesthesia) Monitoring » Post Anesthesia Care

Source page: https://510kreport.com/device/K024245
Methodology: https://510kreport.com/methodology