Cleared Abbreviated

K033256 - ATHENA PELVIC MUSCLE TRAINER II

K033256 is an FDA 510(k) clearance for ATHENA PELVIC MUSCLE TRAINER II, manufactured by Athena Feminine Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Abbreviated 510(k) pathway after a 82-day FDA review.

K033256 · Athena Feminine Technologies, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
82d
Days
Class 2
Risk

K033256 is an FDA 510(k) clearance for the ATHENA PELVIC MUSCLE TRAINER II. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Athena Feminine Technologies, Inc. (Orinda, US). The FDA issued a Cleared decision on December 30, 2003 after a review of 82 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Athena Feminine Technologies, Inc. devices

FDA 510(k) Submission Details - K033256

510(k) Number K033256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2003
Decision Date December 30, 2003
Days to Decision 82 days
Submission Type Abbreviated
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
49d faster than avg
Panel avg: 131d · This submission: 82d
Pathway characteristics
Standards-based clearance path.

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 93
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K033256.
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EVADRI BLADDER CONTROL SYSTEMS
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ELPHA 4 CONTI
K032988 · Danmeter A/S · Dec 2003
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
K030039 · The Prometheus Group · May 2003
ATHENA PELVIC MUSCLE TRAINER
K023905 · Athena Feminine Technologies, Inc. · Apr 2003