Cleared Traditional

K013704 - MEDIPLUS SINGLE USE GI MANOMETRY CATHETER

K013704 is an FDA 510(k) clearance for MEDIPLUS SINGLE USE GI MANOMETRY CATHETER, 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 270-day FDA review.

K013704 · Mediplus , Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
270d
Days
Class 2
Risk

K013704 is an FDA 510(k) clearance for the MEDIPLUS SINGLE USE GI MANOMETRY CATHETER. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Mediplus , Ltd. (St. Petersburg, US). The FDA issued a Cleared decision on August 5, 2002 after a review of 270 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 - K013704

510(k) Number K013704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2001
Decision Date August 05, 2002
Days to Decision 270 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
139d slower than avg
Panel avg: 131d · This submission: 270d
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 K013704.
MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER
K031617 · Mediplus , Ltd. · Jan 2004
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
MANOMETRIC ASSEMBLIES
K983665 · Dentsleeve Pty., Ltd. · May 1999
FLEXILOG LS
K964804 · Oakfield Instruments, Ltd. · Aug 1997
FLEXILOG 3000
K964589 · Oakfield Instruments, Ltd. · Mar 1997