Cleared Traditional

YUWELL? Finger Pulse Oximeter (YX105, YX106, YX110, YX310)

K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology
Feb 2026
Decision
167d
Days
Class 2
Risk

About This 510(k) Submission

K252805 is an FDA 510(k) clearance for the YUWELL? Finger Pulse Oximeter (YX105, YX106, YX110, YX310), a Oximeter (Class II — Special Controls, product code DQA), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on February 17, 2026, 167 days after receiving the submission on September 3, 2025. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K252805 FDA.gov
FDA Decision Cleared SESE
Date Received September 03, 2025
Decision Date February 17, 2026
Days to Decision 167 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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