Cleared Traditional

K134020 - INTONEMV

K134020 is an FDA 510(k) clearance for INTONEMV, manufactured by Incontrol Medical, LLC. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K134020 · Incontrol Medical, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
57d
Days
Class 2
Risk

K134020 is an FDA 510(k) clearance for the INTONEMV. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Incontrol Medical, LLC (Brookfield, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 57 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Incontrol Medical, LLC devices

FDA 510(k) Submission Details - K134020

510(k) Number K134020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2013
Decision Date February 25, 2014
Days to Decision 57 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
74d faster than avg
Panel avg: 131d · This submission: 57d
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 78
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K134020.
InTone
K150180 · Incontrol Medical, LLC · Mar 2015
ELECTRODE FOR URINARY INCONTINENCE
K140265 · Guangzhou Finecure Medical Equipment Co.,Ltd · Jan 2015
APEX
K141158 · Incontrol Medical, LLC · Nov 2014
INTONEMV
K133826 · Incontrol Medical, LLC · Jan 2014
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
K122194 · Everyway Medical Instruments Co.,Ltd · Apr 2013
INWAVE
K121820 · Zynex Medical, Inc. · Aug 2012