Cleared Traditional

K001903 - NEOCONTROL PELVIC FLOOR THERAPY SYSTEM

K001903 is an FDA 510(k) clearance for NEOCONTROL PELVIC FLOOR THERAPY SYSTEM, manufactured by Neotonus, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K001903 · Neotonus, Inc. · Gastroenterology & Urology device
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Aug 2000
Decision
68d
Days
Class 2
Risk

K001903 is an FDA 510(k) clearance for the NEOCONTROL PELVIC FLOOR THERAPY SYSTEM. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Neotonus, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 29, 2000 after a review of 68 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 Neotonus, Inc. devices

FDA 510(k) Submission Details - K001903

510(k) Number K001903 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2000
Decision Date August 29, 2000
Days to Decision 68 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
63d faster than avg
Panel avg: 131d · This submission: 68d
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 58
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K001903.
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SMALL VAGINAL/RECTAL ELECTRODE
K983206 · Empi · Nov 1998
NEOTONUS MODEL 1000 MUSCLE STIMULATOR SYSTEM
K973096 · Neotonus, Inc. · Jun 1998