# K152390: Medke Oximetry Finger Sensor

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Medke Technology Co., Ltd.
- Decided: Aug 18, 2016 after 360 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: 8 generations back to K941811 (1994). 35 ancestors in all.
No later device cites it as a predicate yet.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100077: Nellcor Compatible Reusable SPO2 Soft-Finger Sensor, Model T100A-090103, Solaris Medical Technology, Inc. (2010) Summary page 4.

## Indications for use
Medke Oximetry Finger 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.

Source page: https://510kreport.com/device/K152390
Methodology: https://510kreport.com/methodology