KLA · Class II · 21 CFR 876.1725

FDA Product Code KLA: Monitor, Esophageal Motility, Anorectal Motility, And Tube

Leading manufacturers include Oakfield Instruments, Ltd., Wilson-Cook Medical, Inc. and Sandhill Scientific, Inc..

31
Total
31
Cleared
214d
Avg days
1977
Since
Growing category - 2 submissions in the last 2 years vs 1 in the prior period
Review times improving: avg 142d recently vs 219d historically

FDA 510(k) Cleared Monitor, Esophageal Motility, Anorectal Motility, And Tube Devices (Product Code KLA)

31 devices
1–24 of 31
Cleared Feb 12, 2025
Fecobionics Anorectal System
K242666
Gi Bionics, LLC
Gastroenterology & Urology · 160d
Cleared Dec 06, 2024
RED
K242304
Neuraxis, Inc.
Gastroenterology & Urology · 123d
Cleared Apr 23, 2024
Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212)
K234107
Laborie Medical Technologies, Corp.
Gastroenterology & Urology · 119d
Cleared Mar 08, 2018
THD Anopress with THD SensyProbe
K180135
Thd Spa
Gastroenterology & Urology · 50d
Cleared Mar 14, 2017
THD ANOPRESS
K161785
Thd Spa
Gastroenterology & Urology · 258d
Cleared Jul 07, 2015
mcompass Biofeedback Anorectal Manometry System
K143031
Medspira, LLC
Gastroenterology & Urology · 259d
Cleared Mar 29, 2012
MCOMPASS ANORECTAL MANOMETRY SYSTEM
K120088
Medspira, LLC
Gastroenterology & Urology · 78d
Cleared Apr 13, 2007
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS
K062362
Sarmed Srl
Gastroenterology & Urology · 242d
Cleared Oct 09, 2003
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
K032138
Medtronic Vascular
Gastroenterology & Urology · 90d
Cleared May 17, 1999
MANOMETRIC ASSEMBLIES
K983665
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 210d
Cleared Aug 06, 1997
FLEXILOG LS
K964804
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 250d
Cleared Mar 04, 1997
FLEXILOG 3000
K964589
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 109d
Cleared Nov 04, 1996
FLEXILOG LS 13921
K961895
Oakfield Instruments, Ltd.
Gastroenterology & Urology · 172d
Cleared Jun 11, 1996
ESOPHAGEAL MANOMETRY ANALYSIS MODULE
K961070
Synectics Medical, Inc.
Gastroenterology & Urology · 85d
Cleared Jun 06, 1996
BIOVIEW MODEL S960000
K961056
Sandhill Scientific, Inc.
Gastroenterology & Urology · 80d
Cleared Jun 04, 1996
7100 SWALLOWING WORKSTATION
K954798
Kay Elemetrics Corp.
Gastroenterology & Urology · 230d
Cleared Sep 08, 1995
ANALGRAPH
K941801
Sandhill Scientific, Inc.
Gastroenterology & Urology · 514d
Cleared Dec 13, 1993
MONOCRYSTANT PH/LES CATHETER, MODIFICATION
K914793
Synectics-Dantec
Gastroenterology & Urology · 840d
Cleared Jan 25, 1991
PROVOCATIVE SENSITIVITY BALLOON
K901125
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 319d
Cleared Jul 16, 1990
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
K900239
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 180d
Cleared Mar 18, 1988
PC POLYGRAF
K872712
Synectics-Dantec
Gastroenterology & Urology · 252d
Cleared Nov 22, 1977
PRESSURE MONITOR MANOMETRIC SYS.
K771265
Physio-Control Corp.
Gastroenterology & Urology · 132d
Cleared Nov 22, 1977
HILL TUBE
K771723
Physio-Control Corp.
Gastroenterology & Urology · 70d

About Product Code KLA - Regulatory Context

510(k) Submission Activity

31 total 510(k) submissions under product code KLA since 1977, with 31 receiving FDA clearance (average review time: 214 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 - KLA Product Code

Recent submissions under KLA have taken an average of 142 days to reach a decision - down from 219 days historically, suggesting improved FDA processing for this classification.

KLA devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →