Cleared Traditional

K901125 - PROVOCATIVE SENSITIVITY BALLOON

K901125 is an FDA 510(k) clearance for PROVOCATIVE SENSITIVITY BALLOON, manufactured by Wilson-Cook Medical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KLA cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K901125 · Wilson-Cook Medical, Inc. · Gastroenterology & Urology device
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Jan 1991
Decision
319d
Days
Class 2
Risk

K901125 is an FDA 510(k) clearance for the PROVOCATIVE SENSITIVITY BALLOON. Classified as Monitor, Esophageal Motility, Anorectal Motility, And Tube (product code KLA), Class II - Special Controls.

Submitted by Wilson-Cook Medical, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Wilson-Cook Medical, Inc. devices

FDA 510(k) Submission Details - K901125

510(k) Number K901125 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1990
Decision Date January 25, 1991
Days to Decision 319 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
188d slower than avg
Panel avg: 131d · This submission: 319d
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 21
Devices cleared under the same product code (KLA) and FDA review panel - the closest regulatory comparables to K901125.
7100 SWALLOWING WORKSTATION
K954798 · Kay Elemetrics Corp. · Jun 1996
ANALGRAPH
K941801 · Sandhill Scientific, Inc. · Sep 1995
MONOCRYSTANT PH/LES CATHETER, MODIFICATION
K914793 · Synectics-Dantec · Dec 1993
WILSON-COOK ESOPHAGEAL MOTILITY CATHETER
K900239 · Wilson-Cook Medical, Inc. · Jul 1990
PC POLYGRAF
K872712 · Synectics-Dantec · Mar 1988
PRESSURE MONITOR MANOMETRIC SYS.
K771265 · Physio-Control Corp. · Nov 1977