# K181270: Disposable SpO2 Sensors, Reusable SpO2 Sensors

- Pathway: 510(k) (Traditional)
- Applicant: Orantech, Inc.
- Decided: Sep 7, 2018 after 116 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). 82 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153184: Caremed Reusable & Disposable SPO2 Sensors, Shenzhen Caremed Medical Technology Co., Ltd. (2017) Summary page 6.

## Most influential descendants
- K192608: Disposable SpO2 Sensor (2020), 0 descendants of its own

## Indications for use
The Disposable and Reusable 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 40 kg at hospital facilities.

Source page: https://510kreport.com/device/K181270
Methodology: https://510kreport.com/methodology