LXC — Monitor, Pressure, Intracompartmental Class U

FDA Device Classification

FDA product code LXC covers "Monitor, Pressure, Intracompartmental", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 15 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LXC
Device Class
Class U
Regulation Number
Submission Type
Review Panel
OR
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251900My01MY01 Continuous Compartmental Pressure MonitorJan 16, 2026
K242997My01MY01 Continuous Compartmental Pressure MonitorMar 13, 2025
K223509CompremiumCompremium Compartment Compressibility Monitoring System (CPM#1)Apr 14, 2023
K220952My01MY01 Continuous Compartmental Pressure MonitorMay 24, 2022
K210525My01MY01 Continuous Compartmental Pressure MonitorApr 22, 2021
K202635My01MY01 Continuous Compartmental Pressure MonitorDec 10, 2020
K193321My01MY01 Continuous Compartmental Pressure MonitorJul 30, 2020
K131966Twin Star MedicalTWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SFeb 7, 2014
K090961Twin Star MedicalTWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMSJun 12, 2009
K060963Twin Star MedicalTWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONIJun 6, 2006
K041771Twin Star MedicalTWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETERSep 14, 2004
K031555Synthes (Usa)SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEMJul 8, 2003
K881858Buckman CoACE ICPM SIDE PORTED NEEDLEMay 27, 1988
K873684Ace MedicalACE INTRA COMPARTMENTAL PRESSURE MONITORJan 20, 1988
K844214StrykerCOMPARTMENT SYNDROME PRESSURE MONITOR SYSApr 4, 1985