Cleared Traditional

K031617 - MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER

K031617 is an FDA 510(k) clearance for MEDIPLUS SINGLE USE LOWER GI MANOMETRY ..., manufactured by Mediplus , Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 238-day FDA review.

K031617 · Mediplus , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2004
Decision
238d
Days
Class 2
Risk

K031617 is an FDA 510(k) clearance for the MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Mediplus , Ltd. (Potomac, US). The FDA issued a Cleared decision on January 16, 2004 after a review of 238 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1725 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K031617

510(k) Number K031617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2003
Decision Date January 16, 2004
Days to Decision 238 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 131d · This submission: 238d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KLA Device Classification - Class 2, Special Controls

Product Code KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1725
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KLA Monitor, Esophageal Motility, Anorectal Motility, And Tube

All 26
Devices cleared under the same product code (KLA) and FDA review panel - the closest regulatory comparables to K031617.
mcompass Biofeedback Anorectal Manometry System
K143031 · Medspira, LLC · Jul 2015
MCOMPASS ANORECTAL MANOMETRY SYSTEM
K120088 · Medspira, LLC · Mar 2012
SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS
K062362 · Sarmed Srl · Apr 2007
MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER
K032138 · Medtronic Vascular · Oct 2003
COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500
K022023 · Clinical Innovations, Inc. · Jan 2003
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
K013704 · Mediplus , Ltd. · Aug 2002