Cleared Traditional

YUWELL Finger Pulse Oximeter

K212385 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology
Aug 2022
Decision
379d
Days
Class 2
Risk

About This 510(k) Submission

K212385 is an FDA 510(k) clearance for the YUWELL Finger Pulse Oximeter, 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 August 16, 2022, 379 days after receiving the submission on August 2, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K212385 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2021
Decision Date August 16, 2022
Days to Decision 379 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

Similar Devices — DQA Oximeter

All 721
AViTA Pulse Oximeter (SP61)
K252448 · Avita Corporation · Feb 2026
YUWELL? Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
K252805 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Feb 2026
Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O)
K253109 · Shenzhen Best Electronics Co., Ltd. · Jan 2026
Spo2 Sensor CSS032D
K251751 · Shenzhen Ykd Technology Co., Ltd. · Dec 2025
Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U203S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103S-08); Unimed Reusable SpO2 Sensors (-08 Series) (U103-08)
K251691 · Unimed Medical Supplies, Inc. · Dec 2025
Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-29)
K251696 · Unimed Medical Supplies, Inc. · Dec 2025