# K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jun 26, 2007 after 96 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: 12 generations back to K941811 (1994). 88 ancestors in all.
47 later devices descend from it; 6 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053234: PM-9000 Express Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.
- K032858: The Philips Intellivue MP40, MP50, MP60, MP70,and MP90 Patient Monitors, Release B.O., Philips Medizin Systeme Boblingen GmbH (2003) Summary page 2.
- K012467: Solar 8000M System, General Electric Medical Systems Information Techn (2002) Summary page 2.
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX, Datascope Corp. (2002) Summary page 2.
- K053193: PM-8000 Express Patient Monitor, Model PM-8000 Express, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K072581: PM-60 Pulse Oximeter (2008), 19 descendants of its own
- K072346: PM-7000 Patient Monitor (2007), 19 descendants of its own
- K100046: M Seires Patient Monitor Model M66, M69, M8000, M9000, M7000 (2010), 16 descendants of its own
- K090599: MD300K1 Pulse Oximeter (2009), 9 descendants of its own
- K152563: Pulse Oximeter (MD300M/MD300K2) (2016), 8 descendants of its own

## Indications for use
The PM Series Patient Monitors including-models PM-9000 Express and PM-8000 Express are intended to be used for monitoring, recording, and alarming of multiple physiological parameters in health care facilities by qualified health care professionals trained in the use of the equipment. The physiological parameters that can be monitored by PM-9000 Express Patient Monitor are: ECG(3-lead or 5-lead or 12-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP), Pulse Rate(PR), Carbon Dioxide (CO2), and Anaesthetic Gases(AG). The physiological parameters that can be monitored by PM-8000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), arrhythmia detection, ST Segment analysis, Heart Rate(HR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Pulse Oxygen Saturation (SpO2), Temperature (TEMP), Invasive Blood Pressure(IBP) and Pulse Rate(PR) , and Carbon Dioxide (CO2). Their design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The target populations are human patients ranged from adult to neonate with the exception of the arrhythmia detection and ST Segment analysis, for which the target populations are adult and pediatric only. The PM Series Patient Monitors are not intended for use in a patient's home or residence, or when it has not been ordered by a physician.

Source page: https://510kreport.com/device/K070791
Methodology: https://510kreport.com/methodology