Home / 510(k) Clearances / K252779

510(k) K252779

YUWELL® Electronic Blood Pressure Monitor (YE630CR) by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2026
Date Received
September 2, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

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

  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K242736 — Portable Oxygen Concentrator (Spirit-3) (June 5, 2025)
  • 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 DXN

  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)
  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)
  • K252769 — Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP (October 2, 2025)