# K073280: Beneview T Series Patient Monitors, Models T8, T6 and T5

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 23, 2008 after 215 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: 13 generations back to K941811 (1994). 108 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 111 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 2.
- K041294: Biozdx Hemodynamic Monitor, Cardiodynamics International Corp. (2004) Summary page 2.
- K040183: BISX, Aspect Medical Systems, Inc. (2004) Summary page 2.
- K042601: Capnostat 5, Respironics Novametrix, Inc. (2004) Summary page 2.
- K041790: Datex-Ohmeda S/5 Compact Anesthesia Monitor with L-CANE03 and LCANE03A Software, Datex-Ohmeda (2004) Summary page 2.

## Most influential descendants
- K110922: Patient Monitor (2011), 1 descendant of its own
- K120631: Patient Monitor (2012), 0 descendants of its own

## Indications for use
The BeneView T Series patient monitors including models BeneView T8, BeneView T6 and BeneView T5 are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG(3-1ead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Temperature (TEMP), Pulse Oxygen Saturation (SP02), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure(IBP), carbon dioxide (CO2), anesthetic gas (AG), impedance cardiograph (ICG), bispectral index (BIS) and respiration mechanics (RM). The arrhythmia detection, ST Segment analysis, BIS and RM monitoring are not intended for neonatal patients. The ICG is only for use on adult patients who meet the following requirements: height: 122 to 229cm, weight: 30 to 159kg. Other parameters can be applied to a single adult, pediatric or neonatal patient. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport, hospital ambulance, or home use.

Source page: https://510kreport.com/device/K073280
Methodology: https://510kreport.com/methodology