Cleared Traditional

K183585 - Elitone Device (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183585 · Elidah, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Feb 2019
Decision
52d
Days
Class 2
Risk

K183585 is an FDA 510(k) clearance for the Elitone Device. Classified as Cutaneous Electrode Stimulator For Urinary Incontinence (product code QAJ), Class II - Special Controls.

Submitted by Elidah, Inc. (Monroe, US). The FDA issued a Cleared decision on February 11, 2019 after a review of 52 days - a notably fast clearance cycle.

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: 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 Elidah, Inc. devices

Submission Details

510(k) Number K183585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2018
Decision Date February 11, 2019
Days to Decision 52 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
78d faster than avg
Panel avg: 130d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.