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510(k) K192169

PulsioFlex Monitoring System with ProAQT Sensor by Pulsion Medical Systems SE — Product Code DXG

K192169 is an FDA 510(k) premarket notification submitted by Pulsion Medical Systems SE for the device "PulsioFlex Monitoring System with ProAQT Sensor". The FDA issued a decision of Substantially Equivalent on April 30, 2020. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435. Pulsion Medical Systems SE has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2020
Date Received
August 9, 2019
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 Pulsion Medical Systems SE

  • K171620 — PiCCO Catheter (February 21, 2018)
  • K172259 — PulsioFlex Monitoring System (January 18, 2018)
  • K122121 — PULSIOFLEX MONITORING SYSTEM WITH PICCO MODULE (August 2, 2012)

Other clearances for product code DXG

  • K253092 — Argos Infinity (Rev. 1.0) (February 13, 2026)
  • K251275 — VitalStream ART Connect; VitalStream-Hemo (September 26, 2025)
  • K232048 — Cogent™ Hemodynamic Monitoring System; Cogent™ HMS (December 20, 2023)
  • K212529 — Hypotension Decision Assist Model HDA-OR2 (November 23, 2021)
  • 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