Not Cleared Direct

DEN250009 - VitaSmart Hypothermic Oxygenated Perfusion System (FDA 510(k) Clearance)

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

DEN250009 · Bridge TO Life, Ltd. · Gastroenterology & Urology device
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Jan 2026
Decision
290d
Days
Class 2
Risk

DEN250009 is an FDA 510(k) submission (not cleared) for the VitaSmart Hypothermic Oxygenated Perfusion System. Classified as Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant (product code SGY), Class II - Special Controls.

Submitted by Bridge TO Life, Ltd. (Northbrook, US). The FDA issued a Not Cleared (DENG) decision on January 15, 2026 after a review of 290 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5881 - 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. Elevated predicate reliance profile. With 290 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.

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Submission Details

510(k) Number DEN250009 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 31, 2025
Decision Date January 15, 2026
Days to Decision 290 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
160d slower than avg
Panel avg: 130d · This submission: 290d
Pathway characteristics

Device Classification

Product Code SGY Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5881
Definition A Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant Is A Device That Performs Oxygenated Perfusion Of Liver Grafts At Sub-physiological Temperatures Until It Is Transplanted Into A Recipient Patient. This Generic Type Of Device May Also Include Perfusion Sets, Oxygenators, And Other Components Of The Perfusion Circuit.
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.