# K212385: YUWELL Finger Pulse Oximeter

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Decided: Aug 16, 2022 after 379 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: 4 generations back to K001085 (2000). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101577: Modification to:Fingertip Pulse Oximeter, Model MD300C Series, Beijing Choice Electronic Technololgy Co., Ltd. (2010) Summary page 4.

## Most influential descendants
- K252805: YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (2026), 0 descendants of its own

## Indications for use
The YUWELL@ Finger Pulse Oximeter is a non-invasive, non-sterile, reusable, spot checking device which can measure and display SpO2 and pulse rate through finger. It is intended for adults and children (weight >30 kg) and is expected for home and hospital inspection. The device is not for continuous monitoring,use during motion or for patients with low perfusion.

Source page: https://510kreport.com/device/K212385
Methodology: https://510kreport.com/methodology