# K141441: Menntor X7

- Pathway: 510(k) (Traditional)
- Applicant: Mennen Medical, Ltd.
- Decided: Jan 9, 2015 after 221 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: 3 generations back to K001120 (2001). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093766: Vitalogik 6000/6500, Mennen Medical, Ltd. (2010) Summary page 4.
- K030722: Envoy Patient Monitor, Mennen Medical, Inc. (2004) Summary page 5.

## Indications for use
Menntor X7 is intended for use as a multi-parameter physiological patient monitoring system. The Menntor X7, is a modular monitor with a Multi Parameter Module (MX57, MPM) that can monitor ECG/heart rate, invasive blood pressures , temperature, pulse oximetry, respiration, non-invasive blood pressure, and Cardiac Output The Menntor X7 can also monitor EtCO2, Spirometry and EEG, and display aEEG. The MPM (MX57) is equipped with a battery and can continue monitoring it's vital sign when out of the host Menntor X7 This effectively allows the Menntor X7 to monitor a wide-range of adult, pediatric and neonatal patient conditions, in many different areas of the hospital. Functions include display of multi-parameter waveforms, vital signs, alarm & status messages. The Mennen Medical Menntor X7 is intended for sale as a system for monitoring and recording patient information on any in-hospital application requiring patient monitoring. The following are examples of intended clinical applications: » Critical Care Patients * Cardiac Step-down Units * Emergency Departments * Intra-operative (Anesthesia) Monitoring * Post Anesthesia Care *The Intended Use of the Menntor X7 as indicated above is same as the Indications For Use.

Source page: https://510kreport.com/device/K141441
Methodology: https://510kreport.com/methodology