YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)— 510(k) K252805

Substantially Equivalent

Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

FDA 510(k) clearance K252805 for YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310), Substantially Equivalent on 2026-02-17. Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd..

Clearance details

Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2025-09-03
Decision date: 2026-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danyang, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.