Cleared Traditional

K182022 - ApexMV (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182022 · Incontrol Medical, LLC · Gastroenterology & Urology device
Mar 2019
Decision
231d
Days
Class 2
Risk

K182022 is an FDA 510(k) clearance for the ApexMV. 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 March 15, 2019 after a review of 231 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.

Submission Details

510(k) Number K182022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 27, 2018
Decision Date March 15, 2019
Days to Decision 231 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 156d · This submission: 231d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 7
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K182022.
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · Well-Life Healthcare , Ltd. · Feb 2026
Regenesis EMS Chair
K251026 · Trinity Medical Solutions · Aug 2025
NeuroTrac® MyoPlus Pro (MYO120U)
K243079 · Verity Medical , Ltd. · Jun 2025
BTL-398
K241516 · BTL Industries, Inc. · Feb 2025
Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode
K222528 · Well-Life Healthcare Limited · Dec 2022
Everyway Incontinence Stimulation System
K213116 · Everyway Medical Instruments Co.,Ltd · Dec 2021