LXC

FDA Product Code LXC: Monitor, Pressure, Intracompartmental

Leading manufacturers include MY01, Inc., Twin Star Medical, Inc. and Synthes (Usa).

15
Total
15
Cleared
116d
Avg days
1985
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times increasing: avg 189d recently vs 105d historically

FDA 510(k) Cleared Monitor, Pressure, Intracompartmental Devices (Product Code LXC)

15 devices
1–15 of 15
Cleared Jan 16, 2026
MY01 Continuous Compartmental Pressure Monitor
K251900
MY01, Inc.
Orthopedic · 210d
Cleared Mar 13, 2025
MY01 Continuous Compartmental Pressure Monitor
K242997
MY01, Inc.
Orthopedic · 168d
Cleared Apr 14, 2023
Compremium Compartment Compressibility Monitoring System (CPM#1)
K223509
Compremium AG
Orthopedic · 143d
Cleared May 24, 2022
MY01 Continuous Compartmental Pressure Monitor
K220952
MY01, Inc.
Orthopedic · 53d
Cleared Apr 22, 2021
MY01 Continuous Compartmental Pressure Monitor
K210525
MY01, Inc.
Orthopedic · 58d
Cleared Dec 10, 2020
MY01 Continuous Compartmental Pressure Monitor
K202635
MY01, Inc.
Orthopedic · 90d
Cleared Jul 30, 2020
MY01 Continuous Compartmental Pressure Monitor
K193321
MY01, Inc.
Orthopedic · 241d
Cleared Feb 07, 2014
TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
K131966
Twin Star Medical, Inc.
Orthopedic · 224d
Cleared Jun 12, 2009
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II)
K090961
Twin Star Medical, Inc.
Orthopedic · 67d
Cleared Jun 06, 2006
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR)
K060963
Twin Star Medical
Orthopedic · 60d
Cleared Sep 14, 2004
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM
K041771
Twin Star Medical, Inc.
Orthopedic · 76d
Cleared Jul 08, 2003
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
K031555
Synthes (Usa)
Orthopedic · 50d
Cleared May 27, 1988
ACE ICPM SIDE PORTED NEEDLE
K881858
Buckman Co., Inc.
Orthopedic · 24d
Cleared Jan 20, 1988
ACE INTRA COMPARTMENTAL PRESSURE MONITOR
K873684
Ace Medical Co.
Orthopedic · 128d
Cleared Apr 04, 1985
COMPARTMENT SYNDROME PRESSURE MONITOR SYS
K844214
Stryker Corp.
Orthopedic · 155d

About Product Code LXC - Regulatory Context

510(k) Submission Activity

15 total 510(k) submissions under product code LXC since 1985, with 15 receiving FDA clearance (average review time: 116 days).

Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LXC Product Code

Recent submissions under LXC have taken an average of 189 days to reach a decision - up from 105 days historically. Manufacturers should account for longer review timelines in current project planning.

LXC devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →