Cleared Traditional

K171430 - Incontinence Treatment Device, Model LT2061

K171430 is an FDA 510(k) clearance for Incontinence Treatment Device, manufactured by Shenzhen Dongdixin Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 304-day FDA review.

K171430 · Shenzhen Dongdixin Technology Co., Ltd. · Gastroenterology & Urology device
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Mar 2018
Decision
304d
Days
Class 2
Risk

K171430 is an FDA 510(k) clearance for the Incontinence Treatment Device, Model LT2061. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Shenzhen Dongdixin Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on March 15, 2018 after a review of 304 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 Shenzhen Dongdixin Technology Co., Ltd. devices

FDA 510(k) Submission Details - K171430

510(k) Number K171430 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date March 15, 2018
Days to Decision 304 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
173d slower than avg
Panel avg: 131d · This submission: 304d
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 77
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K171430.
Perfect PFE
K191312 · Tenscare, Ltd. · Nov 2019
ApexMV
K182022 · Incontrol Medical, LLC · Mar 2019
HPM-6000UF
K181497 · BTL Industries, Inc. · Nov 2018
Pelvifine Pelvic Muscle Trainer
K163288 · Shenzhen Konmed Technology Co., Ltd. · Jan 2018
Everyway Incontinence Stimulation System
K161349 · Everyway Medical Instrument Co., Ltd. · Jul 2017
HPM-6000U
K162010 · BTL Industries, Inc. · Dec 2016