Cleared Traditional

K220161 - Biofeedback Nerve and Muscle Stimulator (FDA 510(k) Clearance)

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

K220161 · Shenzhen Konmed Technology Co., Ltd. · Gastroenterology & Urology device
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Jul 2022
Decision
181d
Days
Class 2
Risk

K220161 is an FDA 510(k) clearance for the Biofeedback Nerve and Muscle Stimulator. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Shenzhen Konmed Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 20, 2022 after a review of 181 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 Shenzhen Konmed Technology Co., Ltd. devices

Submission Details

510(k) Number K220161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2022
Decision Date July 20, 2022
Days to Decision 181 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
51d slower than avg
Panel avg: 130d · This submission: 181d
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 Consultant

Guangzhou GLOMED Biological Technology Co., Ltd.
Cassie Lee

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 92
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K220161.
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