Cleared Traditional

K141643 - YARLAP

K141643 is an FDA 510(k) clearance for YARLAP, manufactured by International Trade Group, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K141643 · International Trade Group, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
309d
Days
Class 2
Risk

K141643 is an FDA 510(k) clearance for the YARLAP. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by International Trade Group, Inc. (Oxford, US). The FDA issued a Cleared decision on April 24, 2015 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - 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 International Trade Group, Inc. devices

FDA 510(k) Submission Details - K141643

510(k) Number K141643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2014
Decision Date April 24, 2015
Days to Decision 309 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 130d · This submission: 309d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 54
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K141643.
Incontinence Treatment Device, Model LT2061
K171430 · Shenzhen Dongdixin Technology Co., Ltd. · Mar 2018
Pelvifine Pelvic Muscle Trainer
K163288 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
HPM-6000U
K162010 · BTL Industries, Inc. · Dec 2016
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
K122194 · Everyway Medical Instruments Co.,Ltd · Apr 2013
EVADRI BLADDER CONTROL SYSTEMS
K050483 · Hollister, Inc. · Apr 2005
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc. · Dec 2001