# K252805: YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Feb 17, 2026 after 167 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: 5 generations back to K001085 (2000). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212385: YUWELL Finger Pulse Oximeter, Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. (2022) Summary page 5.

## Indications for use
YUWELL@ Finger Pulse Oximeters are non-invasive, non-sterile, reusable, and spot-checking devices that measure and display SpO2 and pulse rate (PR) via the patient's finger. They are indicated for use in adults and children (weight > 30 kg) and are intended for professional and home settings. These devices are unsuitable for continuous monitoring, use during motion, or in patients with low perfusion.

Source page: https://510kreport.com/device/K252805
Methodology: https://510kreport.com/methodology