# K123711: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Oct 1, 2013 after 301 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). 117 ancestors in all.
13 later devices descend from it; 4 cite it directly.
1 of 131 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093016: Vital Signs Monitor, Shenzhen Creative Industry Co., Ltd. (2010) Summary page 2.
- K053234: PM-9000 Express Patient Monitor, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 2.

## Most influential descendants
- K170047: All-in-One Health Monitor, PC-303 (2017), 6 descendants of its own
- K210086: Vitals360 Multi-Vitals Mobile Monitor (2021), 4 descendants of its own
- K172792: Handheld Pulse Oximeter, Model SP-20 (2018), 3 descendants of its own
- K201468: Pulse Oximeter (2021), 2 descendants of its own
- K212975: MedWand (2022), 1 descendant of its own

## Indications for use
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate, non-invasive blood pressure, functional oxygen saturation, end-tidal C02 concentration, respiration rate, body temperature, and so on, it allows comprehensive analysis of patient's physiological conditions. This instrument is applicable for use in hospitals and clinical institutions. The operation should be performed by qualified professionals only.

Source page: https://510kreport.com/device/K123711
Methodology: https://510kreport.com/methodology