Cleared Traditional

K161349 - Everyway Incontinence Stimulation System

K161349 is an FDA 510(k) clearance for Everyway Incontinence Stimulation System, manufactured by Everyway Medical Instrument Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K161349 · Everyway Medical Instrument Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
417d
Days
Class 2
Risk

K161349 is an FDA 510(k) clearance for the Everyway Incontinence Stimulation System. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Everyway Medical Instrument Co., Ltd. (Shenkeng District, New Taipei City, CN). The FDA issued a Cleared decision on July 7, 2017 after a review of 417 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Everyway Medical Instrument Co., Ltd. devices

FDA 510(k) Submission Details - K161349

510(k) Number K161349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2016
Decision Date July 07, 2017
Days to Decision 417 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
287d slower than avg
Panel avg: 130d · This submission: 417d
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 K161349.
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HPM-6000U
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