Cleared Traditional

Keffort (MC-100, MC-100A) (K213133) - FDA 510(k) Clearance

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

K213133 · Oriental Inspiration Limited · Gastroenterology & Urology device
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Apr 2022
Decision
198d
Days
Class 2
Risk

K213133 is an FDA 510(k) clearance for the Keffort (MC-100, MC-100A). Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Oriental Inspiration Limited (Hong Kong, CN). The FDA issued a Cleared decision on April 13, 2022 after a review of 198 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 Oriental Inspiration Limited devices

Submission Details

510(k) Number K213133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date April 13, 2022
Days to Decision 198 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 130d · This submission: 198d
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 K213133.
Pelvic Floor Muscle Stimulator
K230767 · Nanjing Vishee Medical Technology Co., Ltd. · Sep 2023
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
Biofeedback Nerve and Muscle Stimulator
K220161 · Shenzhen Konmed Technology Co., Ltd. · Jul 2022
Everyway Incontinence Stimulation System
K213116 · Everyway Medical Instruments Co.,Ltd · Dec 2021
Incontinence Probe
K210441 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Sep 2021
MyOnyx System
K201014 · Thought Technology , Ltd. · Jan 2021