# K132026: V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21

- Pathway: 510(k) (Abbreviated)
- Applicant: Mindray DS USA, Inc.
- Decided: Dec 20, 2013 after 172 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K933143 (1994). 35 ancestors in all.
2 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)
- K102004: Endeavour Monitoring System, Mindray DS USA, Inc. (2010) Summary page 1.

## Most influential descendants
- 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
- Jul 31, 2014 · Class II · Z-0107-2015: Mindray DS USA Inc. initiated a voluntary field corrective action for V-Series Patient Monitor because there is an issue with the V-Series Drug Calculator function.

## Indications for use
The V Series 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: * ECG waveform derived from 3, 5.6 and 12 Lead measurements * Heart Rate * Pulse Oximetry (SpO:) * ST Segment Analysis * Arrhythmia Detection * Non Invasive Blood Pressure (NIBP) * Invasive Blood Pressure (IBP) * Cardiac Output (CO) * Respiratory Gasses * Respiration Rate * Temperature The V Series Monitor has the capability of performing IV Drug and Hemodynamic 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 * Cardiac Output for which the target population is adult and pediatric only. The V' Series utilizes the following modules for measuring the indicated parameters: * VPS Module (multi parameter including 3/5/6/12 lead ECG. respiration, pulse oxymetry temperature, non invasive blood pressure and invasive blood pressure) * Temperature Module * Invasive Blood Pressure Module * Cardiac Output Module * Respiratory Gas Module

Source page: https://510kreport.com/device/K132026
Methodology: https://510kreport.com/methodology