FDA Product Code LXC: Monitor, Pressure, Intracompartmental
Leading manufacturers include MY01, Inc., Synthes (Usa) and Compremium AG.
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
Cleared
Jan 16, 2026
MY01 Continuous Compartmental Pressure Monitor
MY01, Inc.
Orthopedic
210d
Cleared
Mar 13, 2025
MY01 Continuous Compartmental Pressure Monitor
MY01, Inc.
Orthopedic
168d
Cleared
Apr 14, 2023
Compremium Compartment Compressibility Monitoring System (CPM#1)
Compremium AG
Orthopedic
143d
Cleared
May 24, 2022
MY01 Continuous Compartmental Pressure Monitor
MY01, Inc.
Orthopedic
53d
Cleared
Apr 22, 2021
MY01 Continuous Compartmental Pressure Monitor
MY01, Inc.
Orthopedic
58d
Cleared
Dec 10, 2020
MY01 Continuous Compartmental Pressure Monitor
MY01, Inc.
Orthopedic
90d
Cleared
Jul 30, 2020
MY01 Continuous Compartmental Pressure Monitor
MY01, Inc.
Orthopedic
241d
Cleared
Jul 08, 2003
SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM
Synthes (Usa)
Orthopedic
50d
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 →