Cleared Traditional

K032138 - MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER

K032138 is an FDA 510(k) clearance for MEDTRONIC SINGLE USE ESOPHAGEAL MANOMET..., manufactured by Medtronic Vascular. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K032138 · Medtronic Vascular · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
90d
Days
Class 2
Risk

K032138 is an FDA 510(k) clearance for the MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANO.... Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on October 9, 2003 after a review of 90 days - within the typical 510(k) review window.

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.

View all Medtronic Vascular devices

FDA 510(k) Submission Details - K032138

510(k) Number K032138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2003
Decision Date October 09, 2003
Days to Decision 90 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
41d faster than avg
Panel avg: 131d · This submission: 90d
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 22
Devices cleared under the same product code (KLA) and FDA review panel - the closest regulatory comparables to K032138.
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
MANOMETRIC ASSEMBLIES
K983665 · Dentsleeve Pty., Ltd. · May 1999
FLEXILOG LS
K964804 · Oakfield Instruments, Ltd. · Aug 1997
FLEXILOG 3000
K964589 · Oakfield Instruments, Ltd. · Mar 1997