# K053234: PM-9000 Express Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: May 4, 2006 after 167 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K941811 (1994). 76 ancestors in all.
71 later devices descend from it; 6 cite it directly.
0 of 148 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043348: Modification to PM-8000 Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2005) Summary page 2.
- K030038: Philips MP60, MP70 and MP90 Intellivue Patient Monitors with Portal Technology and M3185 Opt C41 Wireless Bedside Adaptr, Philips Medical Systems, Inc. (2003) Summary page 2.

## Most influential descendants
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express (2007), 47 descendants of its own
- 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
- K123711: Patient Monitor (2013), 13 descendants of its own

## Recalls of this device
- Sep 5, 2012 · Class II · Z-0742-2013: Mindray has identified an issue with the DPM5 monitors where ST and Arrhythmia features may not be available.

## Indications for use
The PM-9000 Express Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-9000 Express Patient Monitor has many features and functions, yet is easy to use through an integrated keypad, knob and an intuitive menu system. The patient parameters that can be monitored by PM-9000 Express Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Nan-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO 2), Temperature (TEMP), Invasive Blood Pressure(IBPD), Carbon Dioxide (002) and Anaesthetic Gases(AG). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The PM-9000 Express Patient Monitor is intended for use in a health care facility setting. It is intended for use by qualified medical personnel trained in the use of the equipment. The PM-9000 Express Patient Monitor is not recommended 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/K053234
Methodology: https://510kreport.com/methodology