Cleared Traditional

K162010 - HPM-6000U

K162010 is an FDA 510(k) clearance for HPM-6000U, manufactured by BTL Industries, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K162010 · BTL Industries, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
146d
Days
Class 2
Risk

K162010 is an FDA 510(k) clearance for the HPM-6000U. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Framingham, US). The FDA issued a Cleared decision on December 13, 2016 after a review of 146 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K162010

510(k) Number K162010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2016
Decision Date December 13, 2016
Days to Decision 146 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
15d slower than avg
Panel avg: 131d · This submission: 146d
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 96
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K162010.
Incontinence Treatment Device, Model LT2061
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Everyway Incontinence Stimulation System
K161349 · Everyway Medical Instrument Co., Ltd. · Jul 2017
Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15
K161055 · Fuji Dynamics , Ltd. · Jul 2016
Yarlap II
K160773 · International Trade Group, Inc. · May 2016
Urinary Incontinence System
K142369 · Guangzhou Finecure Medical Equipment Co.,Ltd · Jun 2015
K162010 · HPM-6000U
Download PDF FDA Summary BTL Industries, Inc.