Cleared Traditional

K253285 - Elitone for Men (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K253285 · Elidah, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
116d
Days
Class 2
Risk

K253285 is an FDA 510(k) clearance for the Elitone for Men. Classified as Cutaneous Electrode Stimulator For Urinary Incontinence (product code QAJ), Class II - Special Controls.

Submitted by Elidah, Inc. (Newtown, US). The FDA issued a Cleared decision on January 23, 2026 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5330 - 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 Elidah, Inc. devices

Submission Details

510(k) Number K253285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2025
Decision Date January 23, 2026
Days to Decision 116 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
14d faster than avg
Panel avg: 130d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QAJ Cutaneous Electrode Stimulator For Urinary Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5330
Definition A Transcutaneous Electrical Continence Device Consists Of Cutaneous Electrodes That Are Used To Apply External Stimulation To Reduce Urinary Incontinence.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT06620419 Active not recruiting Interventional Industry-sponsored

Clinical Study of External Electrical Stimulation for Male Incontinence

Clinical Evaluation of Perineal Electrical Stimulation for Urinary Incontinence in Men

30
Patients (est.)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Urinary Incontinence
Study design Single group
Eligibility Male only · 18 Years+
Principal investigator Gloria Kolb, MS,MBA
Sponsor Elidah, Inc. (industry)
Started 2024-05-15 → Primary completion 2026-06-30
Primary outcome
Reduction in Leakage by Pad weight
Secondary outcome
Safety measured by no Adverse events
View full study on ClinicalTrials.gov