Cleared Traditional

Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013 (K233576) - FDA 510(k) Clearance

Also marketed or referenced as:
Rectal Probe: KM-502, KM-5018)

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

K233576 · Shenzhen Konmed Technology Co., Ltd. · Gastroenterology & Urology device
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Feb 2024
Decision
108d
Days
Class 2
Risk

K233576 is an FDA 510(k) clearance for the Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-.... Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Shenzhen Konmed Technology Co., Ltd. (Pingshan District, Shenzhen, CN). The FDA issued a Cleared decision on February 23, 2024 after a review of 108 days - within the typical 510(k) review window.

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 K233576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2023
Decision Date February 23, 2024
Days to Decision 108 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
22d faster than avg
Panel avg: 130d · This submission: 108d
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 Technoloy 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 27
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K233576.
BTL-398
K241516 · BTL Industries, Inc. · Feb 2025
Pelvic Floor Stimulator (Intrelief PFE)
K241899 · Easymed Instruments Co., Ltd. · Nov 2024
StarFormer
K234061 · Fotona D.O.O. · Jul 2024
Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes
K231166 · Zmi Electronics , Ltd. · Jan 2024
Unicare (K-UNICARE-USA)
K230983 · Tenscare, Ltd. · Oct 2023
MFG-05
K230780 · Zimmer Medizinsysteme GmbH · Oct 2023