# K150352: V Series Monitoring System (including V12 and V21 Monitors)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 2, 2015 after 203 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: 32 generations back to K941811 (1994). 255 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 257 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132026: V Series Monitoring System, 12.1 Dcu/V12 and 21.0 Dcu/V21, Mindray DS USA, Inc. (2013) Summary page 7.
- K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1), Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd. (2014) Summary page 7.
- K101521: ST/AR ST and Arrhythmia Software Model: Release K.O, Philips Medical Systems (2010) Summary page 7.

## Most influential descendants
- K153448: Passport Series Patient Monitors (Including Passport 8, Passport 12) (2016), 0 descendants of its own

## 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 V12/V21 Monitor include the continuous monitoring of the following human physiological parameters: • ECG waveform derived from 3, 5 and 12 Lead measurements • Heart Rate • ST Segment Analysis • Arrhythmia Detection • 12-lead ECG interpretation • QT Analysis • Pulse Oximetry (SpO2) • Pulse Rate (PR) • Non Invasive Blood Pressure (NIBP) • Invasive Blood Pressure (IBP) • Cardiac Output (C.O.) • Respiratory Gases (O2, CO2) • Respiration Rate (RESP) • Anesthetic Gases (Iso, Enf, Sev, Hal, Des, N2O) • Temperature (TEMP) • Bispectral Index (BIS) The V12/V21 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, ST Segment Analysis and QT Analysis, for which the target population are adult and pediatric only, • IV Drug Calculations for which the target population is adult only, • Cardiac Output for which the target population are adult and pediatric only, and • Bispectral Index(BIS) for which the target population are adult and pediatric only.

Source page: https://510kreport.com/device/K150352
Methodology: https://510kreport.com/methodology