Product code KLA
- Device name
- Monitor, Esophageal Motility, Anorectal Motility, And Tube
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1725
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | 2025-02-12 |
| K242304 | RED | Neuraxis, Inc. | 2024-12-06 |
| K234107 | Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Laborie Medical Technologies, Corp. | 2024-04-23 |
| K180135 | THD Anopress with THD SensyProbe | Thd Spa | 2018-03-08 |
| K161785 | THD ANOPRESS | Thd Spa | 2017-03-14 |
| K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | 2015-07-07 |
| K120088 | MCOMPASS ANORECTAL MANOMETRY SYSTEM | Medspira, LLC | 2012-03-29 |
| K062362 | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS | Sarmed Srl | 2007-04-13 |
| K031617 | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER | Mediplus , Ltd. | 2004-01-16 |
| K032138 | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER | Medtronic Vascular | 2003-10-09 |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 | Clinical Innovations, Inc. | 2003-01-07 |
| K013704 | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER | Mediplus , Ltd. | 2002-08-05 |
| K983665 | MANOMETRIC ASSEMBLIES | Dentsleeve Pty., Ltd. | 1999-05-17 |
| K964804 | FLEXILOG LS | Oakfield Instruments, Ltd. | 1997-08-06 |
| K964589 | FLEXILOG 3000 | Oakfield Instruments, Ltd. | 1997-03-04 |
| K961895 | FLEXILOG LS 13921 | Oakfield Instruments, Ltd. | 1996-11-04 |
| K961070 | ESOPHAGEAL MANOMETRY ANALYSIS MODULE | Synectics Medical, Inc. | 1996-06-11 |
| K961056 | BIOVIEW MODEL S960000 | Sandhill Scientific, Inc. | 1996-06-06 |
| K954798 | 7100 SWALLOWING WORKSTATION | Kay Elemetrics Corp. | 1996-06-04 |
| K941801 | ANALGRAPH | Sandhill Scientific, Inc. | 1995-09-08 |
| K922553 | CLA-COMPUTERIZED LARYNGEAL ANALYZER | H.I.L. Research, Ltd. | 1994-08-23 |
| K914793 | MONOCRYSTANT PH/LES CATHETER, MODIFICATION | Synectics-Dantec | 1993-12-13 |
| K901125 | PROVOCATIVE SENSITIVITY BALLOON | Wilson-Cook Medical, Inc. | 1991-01-25 |
| K900239 | WILSON-COOK ESOPHAGEAL MOTILITY CATHETER | Wilson-Cook Medical, Inc. | 1990-07-16 |
| K884527 | ZINETICS(R) EMC | Zinetics Medical, Inc. | 1989-02-28 |
| K882551 | AMBULATORY PH DATA RECORDER SYSTEM, APH-2000 | Intl. Biomedics, Inc. | 1988-10-12 |
| K872712 | PC POLYGRAF | Synectics-Dantec | 1988-03-18 |
| K821588 | SANDHILL DMS | Sandhill | 1982-06-22 |
| K771723 | HILL TUBE | Physio-Control Corp. | 1977-11-22 |
| K771265 | PRESSURE MONITOR MANOMETRIC SYS. | Physio-Control Corp. | 1977-11-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00851607003006 | QuikLinq FOB Adapter | MEDSPIRA, LLC | 2025-03-10 |
| 00627825014830 | SOLAR Anorectal Manometry Catheter | Laborie Medical Technologies Corp. | 2025-03-06 |
| 68051887046715 | THD Procto Software System | THD SPA | 2025-02-20 |
| 00851607003389 | System Accessory Kit | MEDSPIRA, LLC | 2024-11-30 |
| 68051887043295 | THD Procto Software System | THD SPA | 2023-12-14 |
| 68051887043301 | THD Procto Software System | THD SPA | 2023-12-14 |
| 68051887043318 | THD Procto Software System | THD SPA | 2023-12-14 |
| 68051887043325 | THD Procto Software System | THD SPA | 2023-12-14 |
| 00851607003433 | Extension Tube, mcompass® Catheter, 5-pack | MEDSPIRA, LLC | 2023-10-06 |
| 00851607003426 | Catheter, mcompass®, Biofeedback, 2-channel, 5-pack | MEDSPIRA, LLC | 2023-10-06 |
| 00851607003419 | Catheter, mcompass®, Anorectal Manometry 5-channel, Petite, 5-pack | MEDSPIRA, LLC | 2023-10-06 |
| 00851607003396 | mcompass Anorectal Manometry System | MEDSPIRA, LLC | 2023-10-06 |
| 00851607003372 | Medspira Tablet PC with Power Supply | MEDSPIRA, LLC | 2023-10-06 |
| 00851607003341 | Single Patient Kit, mcompass, Anorectal Manometry 2-channel | MEDSPIRA, LLC | 2023-10-06 |
| 00851607003365 | Battery, FOB | MEDSPIRA, LLC | 2023-07-31 |
| 58051887042642 | THD Procto Software System | THD SPA | 2022-10-07 |
| 18033737712341 | THD Procto Software System | THD SPA | 2022-10-07 |
| 00851607003310 | Medspira mcompass Anorectal Manometry Dock for Tablet PC, w/Power Supply | MEDSPIRA, LLC | 2022-02-04 |
| 18033737712389 | THD Procto Software System | THD SPA | 2021-07-19 |
| 08033737713037 | THD Procto Software System | THD SPA | 2021-07-19 |
| 00851607003181 | mcompass Extension Tube Set | MEDSPIRA, LLC | 2019-06-25 |
| 08033737711279 | THD PressKit | THD SPA | 2017-09-21 |
| 08033737711286 | THD PressProbe | THD SPA | 2017-09-20 |
| 00851607003037 | mcompass Anorectal Manometry Catheter | MEDSPIRA, LLC | 2017-01-06 |
| 00851607003051 | mcompass Anorectal Manometry System | MEDSPIRA, LLC | 2017-01-06 |
| 00851607003068 | mcompass Biofeedback Manometry System | MEDSPIRA, LLC | 2017-01-06 |
| 00851607003075 | mcompass Biofeedback 2-Channel Catheter | MEDSPIRA, LLC | 2017-01-06 |
| 07640172972595 | Latitude Catheter | Unisensor AG | 2016-09-19 |
| 07640172972564 | Latitude Catheter | Unisensor AG | 2016-09-19 |
| 07640172972533 | Latitude Catheter | Unisensor AG | 2016-09-19 |