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510(k) K053395

BP PRO BLOOD PRESSURE MONITOR by Card Guard Scientific Survival , Ltd. — Product Code DXN

K053395 is an FDA 510(k) premarket notification submitted by Card Guard Scientific Survival , Ltd. for the device "BP PRO BLOOD PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on December 23, 2005. The device falls under product code DXN (System, Measurement, Blood-Pressure, Non-Invasive), a Class II device regulated under 21 CFR 870.1130. Card Guard Scientific Survival , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2005
Date Received
December 6, 2005
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 Card Guard Scientific Survival , Ltd.

  • K111745 — KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER (August 1, 2011)
  • K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (April 6, 2011)
  • K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, (July 13, 2010)
  • K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR (June 25, 2010)
  • K083174 — HEALTHEPOD (December 17, 2009)
  • K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM (January 16, 2009)
  • K081257 — CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR (May 29, 2008)
  • K071995 — CG-6108 CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR (December 18, 2007)
  • K061428 — PMP4 APPLICATION (October 16, 2006)
  • K061528 — SELFCHECK GLUCO (September 22, 2006)

Other clearances for product code DXN

  • K261929 — Upper Arm Blood pressure monitor (BP7155D) (September 10, 2026)
  • K254000 — Happy Health Blood Pressure Monitor (September 3, 2026)
  • K262658 — Automatic Digital Blood Pressure monitor (LD-526) (August 31, 2026)
  • K261394 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286 (August 26, 2026)
  • K253425 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P, (August 13, 2026)
  • K261061 — BP Go (BPP-855) (August 13, 2026)
  • K261136 — Blood Pressure Monitor (M501,M501A,M502,M502A,M502C,M502D) (July 23, 2026)
  • K261082 — Microlife Wrist Blood Pressure Monitor , (Model BPHJG5-G) (July 23, 2026)
  • K253126 — Wrist Blood Pressure Monitor (XW-05) (June 18, 2026)
  • K260693 — VicorderCS (VCS-SYS-1100) (June 16, 2026)

FDA data resources