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510(k) K223509

Compremium Compartment Compressibility Monitoring System (CPM#1) by Compremium AG — Product Code LXC

K223509 is an FDA 510(k) premarket notification submitted by Compremium AG for the device "Compremium Compartment Compressibility Monitoring System (CPM#1)". The FDA issued a decision of Substantially Equivalent on April 14, 2023. The device falls under product code LXC (Monitor, Pressure, Intracompartmental), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2023
Date Received
November 22, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Pressure, Intracompartmental
Device Class
Class U
Regulation Number
Review Panel
OR
Submission Type

Other clearances for product code LXC

  • K251900 — MY01 Continuous Compartmental Pressure Monitor (January 16, 2026)
  • K242997 — MY01 Continuous Compartmental Pressure Monitor (March 13, 2025)
  • K220952 — MY01 Continuous Compartmental Pressure Monitor (May 24, 2022)
  • K210525 — MY01 Continuous Compartmental Pressure Monitor (April 22, 2021)
  • K202635 — MY01 Continuous Compartmental Pressure Monitor (December 10, 2020)
  • K193321 — MY01 Continuous Compartmental Pressure Monitor (July 30, 2020)
  • K131966 — TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER S (February 7, 2014)
  • K090961 — TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS (June 12, 2009)
  • K060963 — TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONI (June 6, 2006)
  • K041771 — TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER (September 14, 2004)

FDA data resources