# K082887: PM-1000F+Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Instrumentations, Inc.
- Decided: Jan 16, 2009 after 108 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: 13 generations back to K941811 (1994). 89 ancestors in all.
No later device cites it as a predicate yet.
0 of 90 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.
- K053234: PM-9000 Express Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.
- K070791: PM Series Patient Monitors, Models PM-9000 Express and PM-8000 Express, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2007) Summary page 2.

## Indications for use
The PM-1000F+ Patient Monitor is a vital signs monitor used on human patients The target populations are adult, pediatric and neonatal patients The patient parameters that can be monitored with the PM-1000F+ Patient Monitor are ECG(3-lead or 5-lead selectable), Heart rate (HR), Pulse Rate (PR), Respiration rate (RESP), Non-invasive blood pressure (NIBP), Saturation of Pulse Oxygen (SpO2), Temperature (TEMP), Invasive Blood pressure (IBP), Carbon dioxide (CO2) 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 This 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-1000F+ 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/K082887
Methodology: https://510kreport.com/methodology