Cleared Traditional

MyOnyx System (K201014) - FDA 510(k) Clearance

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

K201014 · Thought Technology , Ltd. · Gastroenterology & Urology device
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Jan 2021
Decision
271d
Days
Class 2
Risk

K201014 is an FDA 510(k) clearance for the MyOnyx System. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Thought Technology , Ltd. (Montreal, CA). The FDA issued a Cleared decision on January 13, 2021 after a review of 271 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 Thought Technology , Ltd. devices

Submission Details

510(k) Number K201014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2020
Decision Date January 13, 2021
Days to Decision 271 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
141d slower than avg
Panel avg: 130d · This submission: 271d
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 27
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K201014.
Keffort (MC-100, MC-100A)
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Everyway Incontinence Stimulation System
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Incontinence Probe
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InMode System with vTone Applicator
K200293 · Inmode , Ltd. · May 2020
Perfect PFE
K191312 · Tenscare, Ltd. · Nov 2019
ApexMV
K182022 · Incontrol Medical, LLC · Mar 2019