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510(k) K251275

VitalStream ART Connect; VitalStream-Hemo by Caretaker Medical — Product Code DXG

K251275 is an FDA 510(k) premarket notification submitted by Caretaker Medical for the device "VitalStream ART Connect; VitalStream-Hemo". The FDA issued a decision of Substantially Equivalent on September 26, 2025. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Caretaker Medical has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2025
Date Received
April 24, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Pre-Programmed, Single-Function
Device Class
Class II
Regulation Number
870.1435
Review Panel
CV
Submission Type

Other clearances by Caretaker Medical

  • 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)
  • K163255 — CareTaker Continuous Non-lnvasive Blood Pressure Monitor, CareTaker Wireless Vit (April 21, 2017)
  • K151499 — CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VIt (March 18, 2016)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • K192169 — PulsioFlex Monitoring System with ProAQT Sensor (April 30, 2020)
  • K193179 — EV1000 Clinical Platform (December 17, 2019)
  • K190955 — Hypotension Decision Assist (November 27, 2019)
  • K181372 — Argos (December 13, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K163334 — LiDCOunity v2 Hemodynamic Monitor (June 5, 2017)
  • K152935 — LiDCOunity Monitor (March 17, 2016)

FDA data resources