# K113183: PMS8210A (Iris) Multi-Parameter Patient Monitor, Model Code 500

- Pathway: 510(k) (Abbreviated)
- Applicant: Shanghai 3f Electronics Co, Ltd.
- Decided: Feb 9, 2012 after 104 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: 12 generations back to K941811 (1994). 78 ancestors in all.
No later device cites it as a predicate yet.
0 of 79 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100394: Multi-Parameter Patient Monitor, Model# PMS8210A, Shanghai 3f Electronics Co, Ltd. (2010) Summary page 2.

## Indications for use
PMS821OA Model Code 500 is a multi-parameters monitor used on human patients. The target populations are adult, pediatric and neonatal patients. The PMS8210A Model Code 500 has certain features and functions. The patient parameters that can be monitored by PMS8210A Model Code 500 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), Temperature (TEMP) and End-tidal C02 (EtCO2) . Its design allows the operator to adjust the settings of parameter alarms that audibly and visually notify the operator when an excursion occurs. The PMS8210A Model Code 500 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 PMS82 I0A Model Code 500 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/K113183
Methodology: https://510kreport.com/methodology