# K231979: Mecun SpO2 sensor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mecun Medical Supply Co., Ltd.
- Decided: Aug 16, 2024 after 408 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: 19 generations back to K941811 (1994). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201360: Reusable and Disposable SpO2 Sensors, Xinkang Medical Instrument Co., Ltd. (2020) Summary page 5.

## Indications for use
Mecun SpO2 sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult patients weighing greater than 40kg. The sensor is intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

Source page: https://510kreport.com/device/K231979
Methodology: https://510kreport.com/methodology