Home / 510(k) Clearances / K232048

510(k) K232048

Cogent™ Hemodynamic Monitoring System; Cogent™ HMS by Icu Medical — Product Code DXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 2023
Date Received
July 10, 2023
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 Icu Medical

  • K250616 — Clave™ Neutral-Displacement Needlefree Connectors (June 5, 2025)
  • K242117 — LifeShield Infusion Safety Software Suite (April 2, 2025)
  • K242114 — Plum Solo™ Precision IV Pump (April 2, 2025)
  • K242115 — Plum Duo™ Precision IV Pump (April 2, 2025)
  • K243985 — Rio™ Drug Reconstitution Transfer Device (January 22, 2025)
  • K223606 — LifeShield™ Infusion Safety Software Suite (August 24, 2023)
  • K223607 — Plum Duo™ Infusion System (August 24, 2023)
  • K192154 — Rio Vial-to-Bag Drug Reconstitution Device (April 20, 2020)
  • K190918 — SwabTip Male Disinfectant Cap (March 6, 2020)
  • K190157 — Diana ChemoClave Transfer Set (October 23, 2019)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • 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)