# K043348: Modification to PM-8000 Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Jan 6, 2005 after 31 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K933143 (1994). 25 ancestors in all.
87 later devices descend from it; 5 cite it directly.
0 of 113 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032733: PM-8000 Patient Monitor, Model 8000, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2004) Summary page 2.

## Most influential descendants
- K053234: PM-9000 Express Patient Monitor (2006), 71 descendants of its own
- K053193: PM-8000 Express Patient Monitor, Model PM-8000 Express (2006), 48 descendants of its own
- 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

## Indications for use
The PM-8000 Patient Monitor is a vital signs monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PM-8000 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 the PM-8000 Patient Monitor are: ECG (3-lead or 5-lead selectable), Heart Rate derived from selected source (SPO2, ECG), Respiration Rate (derived from ECG), Non-Invasive Blood Pressure (NIBP), Saturation of Pulse Oxygen (SpO2), Temperature (TEMP) and invasive pressure (IBP). 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-8000 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-8000 Patient Monitor is not recommended for use in a patient's home or residence, during the patient transport, or when it has not been ordered by a physician.

Source page: https://510kreport.com/device/K043348
Methodology: https://510kreport.com/methodology