Cleared Traditional

K252809 - in2 Smart (in2S) (FDA 510(k) Clearance)

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

K252809 · Virility Medical , Ltd. · Gastroenterology & Urology device
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Apr 2026
Decision
215d
Days
Class 2
Risk

K252809 is an FDA 510(k) clearance for the in2 Smart (in2S). Classified as Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation (product code QRC), Class II - Special Controls.

Submitted by Virility Medical , Ltd. (Hod Hasharon, IL). The FDA issued a Cleared decision on April 6, 2026 after a review of 215 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5026 - 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 Virility Medical , Ltd. devices

Submission Details

510(k) Number K252809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2025
Decision Date April 06, 2026
Days to Decision 215 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
85d slower than avg
Panel avg: 130d · This submission: 215d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QRC Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5026
Definition A Non-implanted Electrical Stimulation Device For Management Of Premature Ejaculation Is Intended To Be Used In Patients With Premature Ejaculation By Delivery Of Electrical Stimulation To The Perineal Muscles And Nerves.
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.