Cleared Traditional

K023905 - ATHENA PELVIC MUSCLE TRAINER

K023905 is an FDA 510(k) clearance for ATHENA PELVIC MUSCLE TRAINER, manufactured by Athena Feminine Technologies, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K023905 · Athena Feminine Technologies, Inc. · Gastroenterology & Urology device
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Apr 2003
Decision
159d
Days
Class 2
Risk

K023905 is an FDA 510(k) clearance for the ATHENA PELVIC MUSCLE TRAINER. 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 April 30, 2003 after a review of 159 days - an extended review 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: 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 Athena Feminine Technologies, Inc. devices

FDA 510(k) Submission Details - K023905

510(k) Number K023905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2002
Decision Date April 30, 2003
Days to Decision 159 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 131d · This submission: 159d
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 93
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K023905.
ATHENA PELVIC MUSCLE TRAINER II
K033256 · Athena Feminine Technologies, Inc. · Dec 2003
ELPHA 4 CONTI
K032988 · Danmeter A/S · Dec 2003
PATHWAY STM-10 PELVIC FLOOR STIMULATOR
K030039 · The Prometheus Group · May 2003
PATHWAY CTS2000 PELVIC FLOOR TRAINING SYSTEM
K023906 · The Prometheus Group · Feb 2003
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc. · Dec 2001
HMT 21, HMT 2000 URINARY INCONTINENCE SYSTEM
K011435 · Hmt, Inc. · Jun 2001