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510(k) K260276

Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro by Shenzhen AOJ Medical Technology Co., Ltd. — Product Code DXN

K260276 is an FDA 510(k) premarket notification submitted by Shenzhen AOJ Medical Technology Co., Ltd. for the device "Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro". The FDA issued a decision of Substantially Equivalent on April 1, 2026. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Shenzhen AOJ Medical Technology Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2026
Date Received
January 29, 2026
Clearance Type
Special
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 Shenzhen AOJ Medical Technology Co., Ltd.

  • K250470 — Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E10 (June 23, 2025)
  • K250161 — Wrist Blood Pressure Monitor (AOJ-35A); Wrist Blood Pressure Monitor (AOJ-35B); (May 2, 2025)
  • K244000 — Arm Blood Pressure Monitor (ARM-30A+);Arm Blood Pressure Monitor (ARM-30G2);Arm (April 30, 2025)
  • K250116 — Arm Blood Pressure Monitor (ARM-30H); Arm Blood Pressure Monitor (ARM-30J); Arm (April 24, 2025)
  • K232989 — Pulse Oximeter (AOJ-70A); Pulse Oximeter (AOJ-70B); Pulse Oximeter (AOJ-70C); Pu (July 1, 2024)
  • K232128 — Infrared Thermometer (AOJ-20A); Infrared Thermometer (AOJ-20Y) (October 14, 2023)
  • K222994 — Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B (July 26, 2023)
  • K221039 — Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20 (December 20, 2022)
  • K222125 — Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, (December 1, 2022)
  • K221170 — Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AO (October 7, 2022)

Other clearances for product code DXN

  • K253126 — Wrist Blood Pressure Monitor (XW-05) (June 18, 2026)
  • K260693 — VicorderCS (VCS-SYS-1100) (June 16, 2026)
  • K253059 — Tournicare ARMA Automatic Blood Pressure Monitor (ARMA-08) (June 15, 2026)
  • K253124 — Upper arm electronic blood pressure monitor (XB-01) (June 3, 2026)
  • K253570 — Blood Pressure Monitor (W06LT) (May 20, 2026)
  • K254048 — Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19 (May 14, 2026)
  • K253152 — BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) (May 6, 2026)
  • K252501 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, D (April 28, 2026)
  • K260260 — Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521 (April 28, 2026)
  • K253982 — Korotkoff sound blood pressure monitor (April 21, 2026)

FDA data resources