KLA · Class II · 21 CFR 876.1725

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

Leading manufacturers include Physio-Control Corp., Wilson-Cook Medical, Inc. and Medtronic Vascular.

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 Oct 09, 2003
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
K032138
Medtronic Vascular
Gastroenterology & Urology · 90d
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 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 →