Cleared Traditional

K233576 - Konmed Incontinence Stimulation Electro...

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

K233576 is an FDA 510(k) clearance for Konmed Incontinence Stimulation Electro..., manufactured by Shenzhen Konmed Technology Co., Ltd.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

FDA 510(k) Submission Details - K233576

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.

KPI Device Classification - Class 2, Special Controls

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 53
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