Cleared Traditional

K260178 - Pelvic Muscle Trainer (KM510

K260178 is an FDA 510(k) clearance for Pelvic Muscle Trainer (KM510, 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 148-day FDA review.

K260178 · Shenzhen Konmed Technology Co., Ltd. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
148d
Days
Class 2
Risk

K260178 is an FDA 510(k) clearance for the Pelvic Muscle Trainer (KM510, KM516B). 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 June 18, 2026 after a review of 148 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 - K260178

510(k) Number K260178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2026
Decision Date June 18, 2026
Days to Decision 148 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 130d · This submission: 148d
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 Peers - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 54
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K260178.
Pelvic Muscle Trainer (PC22A)
K252601 · Hunan Accurate Bio-Medical Technology Co., Ltd. · May 2026
Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303)
K252552 · Shenzhen Changkun Technology Co., Ltd. · May 2026
Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)
K252831 · Dolanvy (Suzhou) Medical Technology Co., Ltd. · Apr 2026
PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02)
K252334 · Pontemedag · Apr 2026
Well-Life Incontinence Stimulation System (WL-2405i(P))
K251760 · Well-Life Healthcare , Ltd. · Feb 2026
Regenesis EMS Chair
K251026 · Trinity Medical Solutions · Aug 2025