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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 94
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K001903.
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc. · Dec 2001
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
K011435 · Hmt, Inc. · Jun 2001
K.E.A.T.
K002154 · Emd Electronic Medical Devices, Corp. · Mar 2001
DETRUSAN 500
K994109 · Innovamed USA, Inc. · Aug 2000
PATHWAY CTS 2000 PELVIC FLOOR TRAINING SYSTEM, MODEL PATHWAY CTS 2000
K001515 · The Prometheus Group · Jul 2000
PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
K993976 · The Prometheus Group · Feb 2000
K001903 · NEOCONTROL PELVIC FLOOR THERAPY SYSTEM
Download PDF FDA Summary Neotonus, Inc.