Cleared Traditional

K141158 - APEX

K141158 is an FDA 510(k) clearance for APEX, 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 205-day FDA review.

K141158 · Incontrol Medical, LLC · Gastroenterology & Urology device
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Nov 2014
Decision
205d
Days
Class 2
Risk

K141158 is an FDA 510(k) clearance for the APEX. 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 November 26, 2014 after a review of 205 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 Incontrol Medical, LLC devices

FDA 510(k) Submission Details - K141158

510(k) Number K141158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2014
Decision Date November 26, 2014
Days to Decision 205 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 slower than avg
Panel avg: 131d · This submission: 205d
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 K141158.
ApexM
K150183 · Incontrol Medical, LLC · Apr 2015
InTone
K150180 · Incontrol Medical, LLC · Mar 2015
ELECTRODE FOR URINARY INCONTINENCE
K140265 · Guangzhou Finecure Medical Equipment Co.,Ltd · Jan 2015
INTONEMV
K134020 · Incontrol Medical, LLC · Feb 2014
INTONEMV
K133826 · Incontrol Medical, LLC · Jan 2014
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
K122194 · Everyway Medical Instruments Co.,Ltd · Apr 2013