# K231243: Finger Clip Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Genial Technology Co., Ltd.
- Decided: Oct 31, 2023 after 183 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Finger Clip Pulse Oximeter is a handheld non-invasive and multi-use device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate in hospitals, hospital-type facilities, and homecare. This device is not recommended for use during exercise or low perfusion scenarios. This device is not intended for use on infants and newborns. (Recommended for people over 3 years and the thickness of finger greater than or equal to 7mm).

Source page: https://510kreport.com/device/K231243
Methodology: https://510kreport.com/methodology