Cleared Traditional

K023906 - PATHWAY CTS2000 PELVIC FLOOR TRAINING S...

K023906 is an FDA 510(k) clearance for PATHWAY CTS2000 PELVIC FLOOR TRAINING S..., manufactured by The Prometheus Group. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K023906 · The Prometheus Group · Gastroenterology & Urology device
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Feb 2003
Decision
89d
Days
Class 2
Risk

K023906 is an FDA 510(k) clearance for the PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by The Prometheus Group (Dover, US). The FDA issued a Cleared decision on February 19, 2003 after a review of 89 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Prometheus Group devices

FDA 510(k) Submission Details - K023906

510(k) Number K023906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2002
Decision Date February 19, 2003
Days to Decision 89 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
41d faster than avg
Panel avg: 130d · This submission: 89d
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 K023906.
HPM-6000U
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K050483 · Hollister, Inc. · Apr 2005
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K013141 · Hollister, Inc. · Dec 2001
ANAL 2 ELECTRODE STIMULATION/EMG PROBE - W/STOP
K990456 · Hollister, Inc. · Mar 1999
SMALL VAGINAL/RECTAL ELECTRODE
K983206 · Empi · Nov 1998