# K123074: Imec, Ipm and Beneview T1 Patient Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jul 3, 2013 after 275 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: 1 generation back to K092449 (2010). 1 ancestor in all.
7 later devices descend from it; 3 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092449: Beneview T Series Patient Monitors, Models Beneview T8, T6 and T5, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2010) Summary page 2.

## Most influential descendants
- K133973: Tempus Pro with Enhanced Features (2014), 3 descendants of its own
- K170567: Tempus Pro Patient Monitor (2017), 2 descendants of its own
- K173768: Tempus Pro Patient Monitor (2018), 1 descendant of its own
- K132662: Passport Series Patient Monitors (2014), 1 descendant of its own
- K201746: Tempus Pro Patient Monitor (2020), 0 descendants of its own

## Indications for use
The iMEC Series Patient Monitors, including iMEC8, iMEC10 and iMEC12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: - C.O. monitoring is restricted to adult patients only; - PAWP monitoring is not intended for neonatal patients; - The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only. The iPM Series Patient Monitors, including iPM 8, iPM 10 and iPM 12, are intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration (Resp), temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), carbon dioxide (CO2), and anesthetic gas (AG). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: - C.O. monitoring is restricted to adult patients only; - PAWP monitoring is not intended for neonatal patients; - The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for adult and pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only. - 12-lead monitoring and AG monitoring are available for iPM 10 and iPM 12 Patient Monitors only. The BeneView T1 Patient Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead, or 5-lead, or 12-lead selectable), arrhythmia detection and ST Segment analysis, heart rate (HR), respiration, temperature, pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), cardiac output (C.O.), and carbon dioxide (CO2). All the parameters can be applied to single adult, pediatric and neonatal patients with the exception of the following: - C.O. monitoring is restricted to adult patients only; - PAWP monitoring is not intended for neonatal patients; - The Mortara ECG Algorithm arrhythmia detection and ST Segment analysis is intended for adult and pediatric patients. The Mindray ECG Algorithm arrhythmia detection is intended for Adult and Pediatric patients, and the Mindray ECG Algorithm ST Segment analysis is intended for adult patients only. The monitors are to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

Source page: https://510kreport.com/device/K123074
Methodology: https://510kreport.com/methodology