Cleared Traditional

K142369 - Urinary Incontinence System

K142369 is an FDA 510(k) clearance for Urinary Incontinence System, manufactured by Guangzhou Finecure Medical Equipment Co.,Ltd. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 296-day FDA review.

K142369 · Guangzhou Finecure Medical Equipment Co.,Ltd · Gastroenterology & Urology device
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Jun 2015
Decision
296d
Days
Class 2
Risk

K142369 is an FDA 510(k) clearance for the Urinary Incontinence System. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Guangzhou Finecure Medical Equipment Co.,Ltd (Guangzhou, CN). The FDA issued a Cleared decision on June 17, 2015 after a review of 296 days - an extended review cycle.

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. 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 Guangzhou Finecure Medical Equipment Co.,Ltd devices

FDA 510(k) Submission Details - K142369

510(k) Number K142369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date June 17, 2015
Days to Decision 296 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
165d slower than avg
Panel avg: 131d · This submission: 296d
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 Consultant

Shenzhen Yoyatech Consulting Co.,Ltd
Field Fu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 87
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K142369.
HPM-6000U
K162010 · BTL Industries, Inc. · Dec 2016
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YARLAP
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K150183 · Incontrol Medical, LLC · Apr 2015