# K030722: Envoy Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Inc.
- Decided: Feb 26, 2004 after 356 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: 2 generations back to K001120 (2001). 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)
- K011784: Modification to Envoy Patient Monitor, Mennen Medical, Ltd. (2001) Summary page 5.

## Most influential descendants
- K141441: Menntor X7 (2015), 0 descendants of its own

## Indications for use
The Envoy is 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, etCO2 and Spirometry. This effectively allows the Envoy to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. The Envoy also includes a spirometer intended for continuous monitoring of adult and pediatric patients with tidal volumes greater than 100mL. Functions include display of multiparameter waveforms, vital signs, and status messages.

Source page: https://510kreport.com/device/K030722
Methodology: https://510kreport.com/methodology