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510(k) K163255

CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vital Signs Monitor, CareTaker Physiological Monitor by Caretaker Medical, LLC — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2017
Date Received
November 21, 2016
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 Caretaker Medical, LLC

  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K213699 — CareTaker Monitor App (March 30, 2022)
  • K211588 — Caretaker Platform, VitalStream Platform, CT5 (August 13, 2021)
  • K181196 — Caretaker Remote Display App and Caretaker Software Library (October 3, 2018)
  • K151499 — CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VIt (March 18, 2016)

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  • 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)