KLA · Monitor, Esophageal Motility, Anorectal Motility, And Tube
Gastroenterology, Urology · 21 CFR 876.1725 · Class 2
Overview
| Product Code | KLA |
|---|---|
| Device Name | Monitor, Esophageal Motility, Anorectal Motility, And Tube |
| Regulation | 21 CFR 876.1725 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 31)
Showing 20 most recent of 31 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242666 | Fecobionics Anorectal System | Gi Bionics, LLC | Feb 12, 2025 | SESE |
| K242304 | RED | Neuraxis, Inc. | Dec 6, 2024 | SESE |
| K234107 | Solar Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) | Laborie Medical Technologies, Corp. | Apr 23, 2024 | SESE |
| K180135 | THD Anopress with THD SensyProbe | Thd Spa | Mar 8, 2018 | SESE |
| K161785 | THD ANOPRESS | Thd Spa | Mar 14, 2017 | SESE |
| K143031 | mcompass Biofeedback Anorectal Manometry System | Medspira, LLC | Jul 7, 2015 | SESE |
| K120088 | MCOMPASS ANORECTAL MANOMETRY SYSTEM | Medspira, LLC | Mar 29, 2012 | SESE |
| K062362 | SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS | Sarmed Srl | Apr 13, 2007 | SESE |
| K031617 | MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER | Mediplus , Ltd. | Jan 16, 2004 | SESE |
| K032138 | MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER | Medtronic Vascular | Oct 9, 2003 | SESE |
| K022023 | COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 | Clinical Innovations, Inc. | Jan 7, 2003 | SESE |
| K013704 | MEDIPLUS SINGLE USE GI MANOMETRY CATHETER | Mediplus , Ltd. | Aug 5, 2002 | SESE |
| K983665 | MANOMETRIC ASSEMBLIES | Dentsleeve Pty., Ltd. | May 17, 1999 | SESE |
| K964804 | FLEXILOG LS | Oakfield Instruments, Ltd. | Aug 6, 1997 | SESE |
| K964589 | FLEXILOG 3000 | Oakfield Instruments, Ltd. | Mar 4, 1997 | SESE |
| K961895 | FLEXILOG LS 13921 | Oakfield Instruments, Ltd. | Nov 4, 1996 | SESE |
| K961070 | ESOPHAGEAL MANOMETRY ANALYSIS MODULE | Synectics Medical, Inc. | Jun 11, 1996 | SESE |
| K961056 | BIOVIEW MODEL S960000 | Sandhill Scientific, Inc. | Jun 6, 1996 | SESE |
| K954798 | 7100 SWALLOWING WORKSTATION | Kay Elemetrics Corp. | Jun 4, 1996 | SESE |
| K941801 | ANALGRAPH | Sandhill Scientific, Inc. | Sep 8, 1995 | SESE |
Top Applicants
- Oakfield Instruments, Ltd. — 3 clearances
- Mediplus , Ltd. — 2 clearances
- Medspira, LLC — 2 clearances
- Physio-Control Corp. — 2 clearances
- Sandhill Scientific, Inc. — 2 clearances
