Cleared Traditional

K253525 - Urocross Expander System (Model Numbers ES2018 and ES3025) (FDA 510(k) Clearance)

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

K253525 · Prodeon Medical, Inc. · Gastroenterology & Urology device
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Mar 2026
Decision
119d
Days
Class 2
Risk

K253525 is an FDA 510(k) clearance for the Urocross Expander System (Model Numbers ES2018 and ES3025). Classified as Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia (product code QKA), Class II - Special Controls.

Submitted by Prodeon Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 12, 2026 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5510 - 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 Prodeon Medical, Inc. devices

Submission Details

510(k) Number K253525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2025
Decision Date March 12, 2026
Days to Decision 119 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
11d faster than avg
Panel avg: 130d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QKA Temporarily-placed Urethral Opening System For Symptoms Of Benign Prostatic Hyperplasia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5510
Definition A System Intended For The Treatment Of Symptoms Due To Urinary Outflow Obstruction Secondary To Benign Prostatic Hyperplasia (bph) In Men Age 50 And Above.
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
NCT05400980 Active not recruiting Interventional Industry-sponsored

Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath

The Expander-2 Trial: A Multi-Center, Randomized, Blinded, Controlled Study to Evaluate the Safety and Efficacy of the Urocross® Expander System and Retrieval Sheath

240
Patients (est.)
2
Sites
Treatment
Purpose
Double blind
Masking
Condition studied Benign Prostatic Hyperplasia
Study design Parallel
Eligibility Male only · 45 Years+
Principal investigator Kevin T. McVary
Sponsor Prodeon Medical, Inc (industry)
Started 2022-07-05 → Primary completion 2025-09-01 → Completed 2028-12-01
Primary outcome
Safety of Urocross Expander Implant
Secondary outcome
Percent change in Total IPSS for subjects randomized to the Urocross Implant
View full study on ClinicalTrials.gov