Home / 510(k) Clearances / K251143

510(k) K251143

Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) by Ningbo Ranor Medical Science & Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
April 14, 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 Ningbo Ranor Medical Science & Technology Co., Ltd.

  • K200578 — Infrared Thermometer Model Number RN-50A,RN-50B (July 16, 2020)
  • K193456 — Arm Blood Pressure Monitor (July 16, 2020)
  • K200471 — Infrared Thermometer Model Number RN-60A,RN-60B (June 19, 2020)

Other clearances for product code DXN

  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • 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)
  • 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)