Home / 510(k) Clearances / K122400

510(k) K122400

CARDIOX FLOW DETECTION SYSTEM by Cardiox Corp. — Product Code DXG

K122400 is an FDA 510(k) premarket notification submitted by Cardiox Corp. for the device "CARDIOX FLOW DETECTION SYSTEM". The FDA issued a decision of Substantially Equivalent on November 5, 2013. The device falls under product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function), a Class II device regulated under 21 CFR 870.1435.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2013
Date Received
August 7, 2012
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 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)
  • 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)

FDA data resources