Cleared Traditional

K243052 - Glean Urodynamics System Male Delivery System (GUS-1000-M) (FDA 510(k) Clearance)

Also includes:
Glean Urodynamics System Female Delivery System (GUS-1000-F) Glean Urodynamics System Uroflowmeter (UFM-1000 (Uroflowmeter))

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

K243052 · Bright Uro, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
178d
Days
Class 2
Risk

K243052 is an FDA 510(k) clearance for the Glean Urodynamics System Male Delivery System (GUS-1000-M). Classified as Cystometer, Electrical Recording (product code EXQ), Class II - Special Controls.

Submitted by Bright Uro, Inc. (Irvine, US). The FDA issued a Cleared decision on March 24, 2025 after a review of 178 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1620 - 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 Bright Uro, Inc. devices

Submission Details

510(k) Number K243052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2024
Decision Date March 24, 2025
Days to Decision 178 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
48d slower than avg
Panel avg: 130d · This submission: 178d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EXQ Cystometer, Electrical Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1620
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
NCT05959655 Completed Interventional Industry-sponsored

Modern Urodynamics System Efficacy (MUSE) Study

38
Patients (actual)
5
Sites
Device_feasibility
Purpose
Open label
Masking
Condition studied Urologic Diseases; Urodynamics
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Brittany Carter, DHSc, MPH
Sponsor Bright Uro (industry)
Started 2023-08-21 → Primary completion 2024-04-18
Primary outcome
Percentage of Participants With Insertion Success
Secondary outcome
Percentage of Participants Rating Overall Comfort of Glean Urodynamics as Comfortable or Extremely Comfortable
View full study on ClinicalTrials.gov