Cleared Traditional

K030039 - PATHWAY STM-10 PELVIC FLOOR STIMULATOR

K030039 is an FDA 510(k) clearance for PATHWAY STM-10 PELVIC FLOOR STIMULATOR, 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 137-day FDA review.

K030039 · The Prometheus Group · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
137d
Days
Class 2
Risk

K030039 is an FDA 510(k) clearance for the PATHWAY STM-10 PELVIC FLOOR STIMULATOR. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by The Prometheus Group (Duxbury, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 137 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 The Prometheus Group devices

FDA 510(k) Submission Details - K030039

510(k) Number K030039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2003
Decision Date May 23, 2003
Days to Decision 137 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
7d slower than avg
Panel avg: 130d · This submission: 137d
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 K030039.
HPM-6000U
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K050483 · Hollister, Inc. · Apr 2005
MICROGYN PLUS STIMULATION DEVICE
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