# K192343: Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Creative Industry Co., Ltd.
- Decided: Dec 31, 2019 after 125 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- 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). 118 ancestors in all.
No later device cites it as a predicate yet.
1 of 119 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123711: Patient Monitor, Shenzhen Creative Industry Co., Ltd. (2013) Summary page 5.

## Indications for use
This Patient Monitor is a multi-functional instrument designed for monitoring the vital physiological signs of adult and pediatric (but not neonatal) patients. With the functions of real-time recording and displaying parameters, such as ECG, heart rate(HR), non-invasive blood pressure (NIBP), functional oxygen saturation (SpO2), respiration rate (RESP), body temperature (TEMP), end-tidal CO2 concentration (EtCO?2), 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/K192343
Methodology: https://510kreport.com/methodology