Product code LXC
- Device name
- Monitor, Pressure, Intracompartmental
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251900 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2026-01-16 |
| K242997 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2025-03-13 |
| K223509 | Compremium Compartment Compressibility Monitoring System (CPM#1) | Compremium AG | 2023-04-14 |
| K220952 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2022-05-24 |
| K210525 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2021-04-22 |
| K202635 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020-12-10 |
| K193321 | MY01 Continuous Compartmental Pressure Monitor | MY01, Inc. | 2020-07-30 |
| K131966 | TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM | Twin Star Medical, Inc. | 2014-02-07 |
| K090961 | TWIN STAR COMPARTMENT PRESSURE MONITOR AND FLUID COLLECTION CATHETER SYSTEM (CMS-II) | Twin Star Medical, Inc. | 2009-06-12 |
| K060963 | TWIN STAR COMPARTMENT PRESSURE MONITORING AND FLUID COLLECTION MONITOR (CMS MONITOR) | Twin Star Medical | 2006-06-06 |
| K041771 | TWIN STAR COMPARTMENT SYNDROME PRESSURE MONITORING AND FLUID COLLECTION CATHETER SYSTEM | Twin Star Medical, Inc. | 2004-09-14 |
| K031555 | SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM | Synthes (Usa) | 2003-07-08 |
| K881858 | ACE ICPM SIDE PORTED NEEDLE | Buckman Co., Inc. | 1988-05-27 |
| K873684 | ACE INTRA COMPARTMENTAL PRESSURE MONITOR | Ace Medical Co. | 1988-01-20 |
| K844214 | COMPARTMENT SYNDROME PRESSURE MONITOR SYS | Stryker Corp. | 1985-04-04 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10840199544223 | Rhoton Spetzler Type Set | KOROS U.S.A., INC. | 2022-12-31 |
| 10810063754669 | Safco Nitrilex Black Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754843 | Safco Nitrilex Prevail Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754829 | Safco Nitrilex Prevail Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754812 | Safco Nitrilex Prevail Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754799 | Safco Nitrilex Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754782 | Safco Nitrilex Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754775 | Safco Nitrilex Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754768 | Safco Nitrilex Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754751 | Safco Nitrilex Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754737 | Safco Nitrilex UltraSoft Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754720 | Safco Nitrilex UltraSoft Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754713 | Safco Nitrilex UltraSoft Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754706 | Safco Nitrilex UltraSoft Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754690 | Safco Nitrilex Black Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754683 | Safco Nitrilex Black Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754676 | Safco Nitrilex Black Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754652 | Safco Nitrilex Black Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 10810063754744 | Safco Nitrilex UltraSoft Gloves | SAFCO DENTAL SUPPLY CO. | 2022-11-29 |
| 30850007350049 | Quick Pressure Monitor Set - 20G | C2DX, INC. | 2022-05-03 |
| 20850007350042 | Quick Pressure Monitor Set (Japan) - 20G | C2DX, INC. | 2022-05-03 |
| 10850007350182 | Side Ported Needle - 20G | C2DX, INC. | 2022-05-03 |
| 10850007350038 | Side Ported Needle | C2DX, INC. | 2020-04-08 |
| 10850007350045 | Syringe, 3cc | C2DX, INC. | 2020-04-08 |
| 10850007350021 | Quick Pressure Monitor Set (Japan) | C2DX, INC. | 2020-04-08 |
| 10850007350014 | Quick Pressure Monitor Set | C2DX, INC. | 2020-04-08 |
| 10850007350007 | Indwelling Slit Catheter | C2DX, INC. | 2020-04-08 |
| 10886982239860 | NA | Synthes GmbH | 2016-12-31 |
| 10886982239884 | NA | SYNTHES (U.S.A.) LP | 2016-12-31 |
| 10886982239914 | NA | Synthes GmbH | 2016-12-31 |