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510(k) K122013

MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M) by Microlife Corp. — Product Code DXN

K122013 is an FDA 510(k) premarket notification submitted by Microlife Corp. for the device "MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, CARDIO+ (BP4GAPO-2M)". The FDA issued a decision of Substantially Equivalent on May 13, 2013. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Microlife Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2013
Date Received
July 10, 2012
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 Microlife Corp.

  • K080337 — MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D (May 13, 2008)
  • K073398 — MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3MK1-3 (BP W100) (December 20, 2007)
  • K073397 — MICROLIFE UPPER ARM MANUAL BLOOD PRESSURE MONITOR, MODEL BP3MR1-H (BP A50) (December 20, 2007)
  • K041411 — MICROLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL BP-3BTO-AP (July 21, 2004)
  • K031024 — MICROLIFE ELECTRONIC PEAK FLOW MONITOR, MODEL PF-100 (November 14, 2003)
  • K030961 — MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921 (September 12, 2003)
  • K021305 — MICROLIFE WRIST WATCH BLOOD PRESSURE, MODEL BP-3BU1-5, WITH OPTIONAL THERMAL PRI (June 28, 2002)
  • K020725 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL IR1DE1 (March 12, 2002)
  • K013485 — MICROLIFE UPPER ARM AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP-3BTO-1, WITH OPTI (January 17, 2002)
  • K003308 — MICROLIFE DIGITAL INFRARED EAR THERMOMETER, IR1DAI, IR1DB1, IR1DD1 (November 14, 2000)

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