# K092449: Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Aug 30, 2010 after 385 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
35 later devices descend from it; 5 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K132075: Passport M Series Patient Monitoring (Including Models Passport 17M and Passport 12M) (2014), 10 descendants of its own
- K143195: Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) (2014), 9 descendants of its own
- K160981: Patient Monitor (2016), 8 descendants of its own
- K123211: A5 Anesthesia Delivery System (2013), 8 descendants of its own
- K123074: Imec, Ipm and Beneview T1 Patient Monitors (2013), 7 descendants of its own

## Recalls of this device
- Aug 31, 2026 · Class III · Z-0113-2027: Certain monitor operator's manuals contain descriptions that may be insufficient or may require clarification regarding selected physiological alarm functions
- Jul 27, 2015 · Class II · Z-2737-2015: The DPM 7 Monitors may display a black screen.
- Oct 6, 2014 · Class II · Z-0837-2015: Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an incorrect IBP tile on the monitors display.
- Mar 5, 2014 · Class II · Z-1611-2014: The MPM included a cardiac ST/Arrhythmia analysis feature which is not cleared for marketing.
- Aug 11, 2010 · Class II · Z-0513-2013: There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailable : Full Disclosure, Drug, Hemodynamic Calculations, Renal Calculations, Oxygenation Calculations, and

Source page: https://510kreport.com/device/K092449
Methodology: https://510kreport.com/methodology