Not Cleared Direct

DEN130044 - INFLOW INTRAURETHRAL VALVE-PUMP (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN130044 · Vesiflo, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
354d
Days
Class 2
Risk

DEN130044 is an FDA 510(k) submission (not cleared) for the INFLOW INTRAURETHRAL VALVE-PUMP. Classified as Urethral Insert With Pump For Bladder Drainage (product code PIH), Class II - Special Controls.

Submitted by Vesiflo, Inc. (Redmond, US). The FDA issued a Not Cleared (DENG) decision on October 14, 2014 after a review of 354 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5140 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 354 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Vesiflo, Inc. devices

Submission Details

510(k) Number DEN130044 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 25, 2013
Decision Date October 14, 2014
Days to Decision 354 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 130d · This submission: 354d
Pathway characteristics

Device Classification

Product Code PIH Urethral Insert With Pump For Bladder Drainage
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5140
Definition The Device Is Intended To Empty Urine From The Bladder Under Patient Control.
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.