# K100394: Multi-Parameter Patient Monitor, Model# PMS8210A

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai 3f Electronics Co, Ltd.
- Decided: Apr 15, 2010 after 58 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: 11 generations back to K941811 (1994). 77 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 79 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.

## Most influential descendants
- K113183: PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500 (2012), 0 descendants of its own

## Indications for use
The PMS821 OA Multi Parameter Patient Monitor is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS821 OA Patient Monitor has certain features and functions. The patient parameters that can be monitored by PMS8210OA Patient Monitor are: ECG(3-lead or 5-lead selectable), Heart Rate(HR), Pulse Rate(PR), Respiration Rate(RESP), Non-invasive Blood Pressure (NIBP), Arterial Hemoglobin Oxygen Saturation(SpO2) and Temperature (TEMP). Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The PMS821IOA 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 PMS821OA 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/K100394
Methodology: https://510kreport.com/methodology