Product code LXC ยท Class U
Monitor, Pressure, Intracompartmental
1510(k)s in 12 months (15 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in LXC
| Company | 510(k)s | Recalls |
|---|---|---|
| MY01, Inc. | 6 | 1 |
| Twin Star Medical | 4 | 0 |
| Ace Medical Co. | 1 | 0 |
| Buckman Co., Inc. | 1 | 0 |
| Compremium AG | 1 | 0 |
| Stryker Corp. | 1 | 0 |
| Stryker Instruments Div. of Stryker Corporation | 0 | 1 |
| Synthes (Usa) | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 16, 2026 | K251900 | MY01 Continuous Compartmental Pressure Monitor MY01, Inc., CA | LXC |
| Mar 13, 2025 | K242997 | MY01 Continuous Compartmental Pressure Monitor MY01, Inc., CA | LXC |
| Apr 14, 2023 | K223509 | Compremium Compartment Compressibility Monitoring System (CPM#1) Compremium AG, CH | LXC |
| May 24, 2022 | K220952 | MY01 Continuous Compartmental Pressure Monitor MY01, Inc., CA | LXC |
| Apr 22, 2021 | K210525 | MY01 Continuous Compartmental Pressure Monitor MY01, Inc., CA | LXC |
| Dec 10, 2020 | K202635 | MY01 Continuous Compartmental Pressure Monitor MY01, Inc., CA | LXC |
| Jul 30, 2020 | K193321 | MY01 Continuous Compartmental Pressure Monitor MY01, Inc., CA | LXC |
| Feb 7, 2014 | K131966 | TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM Twin Star Medical, Inc. | LXC |
| Jun 12, 2009 | K090961 | TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) Twin Star Medical, Inc. | LXC |
| Jun 6, 2006 | K060963 | TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) Twin Star Medical | LXC |
| Sep 14, 2004 | K041771 | TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM Twin Star Medical, Inc. | LXC |
| Jul 8, 2003 | K031555 | SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM Synthes (Usa) | LXC |
| May 27, 1988 | K881858 | ACE ICPM SIDE PORTED NEEDLE Buckman Co., Inc. | LXC |
| Jan 20, 1988 | K873684 | ACE INTRA COMPARTMENTAL PRESSURE MONITOR Ace Medical Co. | LXC |
| Apr 4, 1985 | K844214 | COMPARTMENT SYNDROME PRESSURE MONITOR SYS Stryker Corp. | LXC |
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