# K201360: Reusable and Disposable SpO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Xinkang Medical Instrument Co., Ltd.
- Decided: Aug 19, 2020 after 90 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: 18 generations back to K941811 (1994). 86 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142832: Unimed Disposable and Reusable SPO2 Sensors, Unimed Medical Supplies, Inc. (2015) Summary page 5.

## Most influential descendants
- K231979: Mecun SpO2 sensor (2024), 0 descendants of its own

## Indications for use
The Reusable and Disposable SPO2 Sensors are 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 sensors are intended to be used in hospital settings where patient care is offered by qualified healthcare personnel.

Source page: https://510kreport.com/device/K201360
Methodology: https://510kreport.com/methodology