Home / 510(k) Clearances / K210770

510(k) K210770

Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor by Andon Health Co, Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2021
Date Received
March 15, 2021
Clearance Type
Abbreviated
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 Andon Health Co, Ltd.

  • K251113 — iHealth Compare Wireless Blood Pressure Monitor(BP-300C);iHealth Compare Pro Wir (August 4, 2025)
  • K241394 — iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (December 20, 2024)
  • K234041 — Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA); Fully Automatic E (April 22, 2024)
  • K222869 — Arm Blood Pressure Monitor (February 15, 2023)
  • K222867 — AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) (December 21, 2022)
  • K212598 — iHealth infrared Ear thermometer PT5 (January 28, 2022)
  • K210768 — Wrist Blood Pressure Monitor, Blood Pressure Monitor (July 30, 2021)
  • K202753 — iHealth Wireless No-Touch Forehead Thermometer (March 8, 2021)
  • K202791 — iHealth Clinical Digital Thermometer (January 5, 2021)
  • K201380 — Livocare Surgical Mask (October 7, 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)
  • 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)