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510(k) K252805

YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2026
Date Received
September 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.

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  • K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT (May 22, 2025)
  • K213825 — Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A (April 28, 2023)
  • K221372 — YUWELL Electronic Blood Pressure Monitor (October 17, 2022)
  • K212385 — YUWELL Finger Pulse Oximeter (August 16, 2022)
  • K203583 — YUWELL infrared ear thermometer: YHT101, YHT200 (May 20, 2021)
  • K201864 — YUWELL Infrared Thermometer (December 7, 2020)
  • K200939 — Electronic Blood Pressure Monitor (August 20, 2020)

Other clearances for product code DQA

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  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
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  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)
  • K241086 — Avidhrt Sense SpO2 (May 9, 2025)