LXC · Monitor, Pressure, Intracompartmental

· Class U

Overview

Product Code	LXC
Device Name	Monitor, Pressure, Intracompartmental
Device Class	Class U
Review Panel

Record	Device Name	Applicant	Decision Date	Decision
K251900	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	Jan 16, 2026	SESE
K242997	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	Mar 13, 2025	SESE
K223509	Compremium Compartment Compressibility Monitoring System (CPM#1)	Compremium AG	Apr 14, 2023	SESE
K220952	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	May 24, 2022	SESE
K210525	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	Apr 22, 2021	SESE
K202635	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	Dec 10, 2020	SESE
K193321	MY01 Continuous Compartmental Pressure Monitor	MY01, Inc.	Jul 30, 2020	SESE
K131966	TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM	Twin Star Medical, Inc.	Feb 7, 2014	SESE
K090961	TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)	Twin Star Medical, Inc.	Jun 12, 2009	SESE
K060963	TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)	Twin Star Medical	Jun 6, 2006	SESE
K041771	TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM	Twin Star Medical, Inc.	Sep 14, 2004	SESE
K031555	SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM	Synthes (Usa)	Jul 8, 2003	SESE
K881858	ACE ICPM SIDE PORTED NEEDLE	Buckman Co., Inc.	May 27, 1988	SESE
K873684	ACE INTRA COMPARTMENTAL PRESSURE MONITOR	Ace Medical Co.	Jan 20, 1988	SESE
K844214	COMPARTMENT SYNDROME PRESSURE MONITOR SYS	Stryker Corp.	Apr 4, 1985	SESE