# K102004: Endeavour Monitoring System

- Pathway: 510(k) (Abbreviated)
- Applicant: Mindray DS USA, Inc.
- Decided: Sep 10, 2010 after 57 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K933143 (1994). 34 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062098: Spectrum Monitor, Model 0998-00-1000-Xxxxx, Datascope Corp. (2007) Summary page 1.
- K983575: Accutorr Plus Non Invasive Blood Pressure Monitor, Model # 0998-00-0117-XX, Datascope Corp. (1999) Summary page 1.

## Most influential descendants
- K132026: V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21 (2013), 2 descendants of its own
- K150352: V Series Monitoring System (including V12 and V21 Monitors) (2015), 1 descendant of its own
- K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own

## Recalls of this device
- Oct 7, 2013 · Class II · Z-0389-2014: Mindray has identified an issue with V Series Monitor where the V Dock power pins connecting the V Series Monitor to the V Dock may lose spring tension, potentially causing the screen to temporarily g
- Sep 24, 2012 · Class II · Z-0528-2013: Mindray has identified an issue with the V Series Monitor where the monitors touch screen may stop responding to touch.
- May 7, 2012 · Class II · Z-2279-2012: Mindray has identified two software anomalies contained in the V Series Monitoring System. There have been no reports of injuries associated with these anomalies. These anomalies affect V Series Syste

## Indications for use
The Endeavour Monitoring System is intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. The Indications for Use for the Endeavour include the monitoring of the following human physiological parameters: * EGG waveform derived from 3, 5, 6 and 12 lead measurements * Heart Rate * Pulse Oximetry (SPO2) * ST Segment Analysis * Arrhythmnia Detection * Non Invasive Blood Pressure (NIBP) * Invasive Blood Pressure (1BP) * Cardiac Output (GO) * Respiratory Gasses * Respiration Rate * Temperature The Endeavour Monitor has the capability of performing rV Drug and Hemodynamnic Calculations and interfacing with network devices. The target populations are adult, pediatric and neonate with the exception of: * Arrhythmia detection and ST Segment Analysis, for which the target populations are adult and pediatric only, * IV Drug Calculations for which the target population is adult only, and a Cardiac Output for which the target population is adult and pediatric only.

Source page: https://510kreport.com/device/K102004
Methodology: https://510kreport.com/methodology