Atlas FDA

LXC

15 FDA 510(k) clearances · Product code

90 daysmedian time to decision
224 days90th percentile
15clearances measured

FDA profile

Official device name
Monitor, Pressure, Intracompartmental
Device class
Unclassified
Medical specialty
Unknown
Adverse events (MAUDE)
1994: 1 · 1996: 1 · 2013: 8
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
MY01 Continuous Compartmental Pressure Monitor (K251900)MY01, Inc.2026-01-16
MY01 Continuous Compartmental Pressure Monitor (K242997)MY01, Inc.2025-03-13
Compremium Compartment Compressibility Monitoring System (CPM#1) (K223509)Compremium AG2023-04-14
MY01 Continuous Compartmental Pressure Monitor (K220952)MY01, Inc.2022-05-24
MY01 Continuous Compartmental Pressure Monitor (K210525)MY01, Inc.2021-04-22
MY01 Continuous Compartmental Pressure Monitor (K202635)MY01, Inc.2020-12-10
MY01 Continuous Compartmental Pressure Monitor (K193321)MY01, Inc.2020-07-30
TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM (K131966)Twin Star Medical, Inc.2014-02-07
TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) (K090961)Twin Star Medical, Inc.2009-06-12
TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) (K060963)Twin Star Medical2006-06-06
TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM (K041771)Twin Star Medical, Inc.2004-09-14
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM (K031555)Synthes (Usa)2003-07-08
ACE ICPM SIDE PORTED NEEDLE (K881858)Buckman Co., Inc.1988-05-27
ACE INTRA COMPARTMENTAL PRESSURE MONITOR (K873684)Ace Medical Co.1988-01-20
COMPARTMENT SYNDROME PRESSURE MONITOR SYS (K844214)Stryker Corp.1985-04-04

Track LXC automatically

Every clearance here is in the API, with alerts when new ones post.