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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / DEN250009

510(k) cleared

VitaSmart Hypothermic Oxygenated Perfusion System

Bridge TO Life, Ltd. · Jan 15, 2026 · DEN250009

FDA cleared the VitaSmart Hypothermic Oxygenated Perfusion System from Bridge TO Life, Ltd. on Jan 15, 2026 under DEN250009, a direct 510(k). The device falls under product code SGY, Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant, regulated at 21 CFR 876.5881 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Mar 31, 2025. The decision came 290 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Bridge TO Life, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under DEN250009?

DEN250009 is the FDA 510(k) for VitaSmart Hypothermic Oxygenated Perfusion System, submitted by Bridge TO Life, Ltd.. FDA's decision date was Jan 15, 2026, under product code SGY (Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant).

Who makes the VitaSmart Hypothermic Oxygenated Perfusion System?

Bridge TO Life, Ltd., based in Northbrook, IL, is the applicant of record for DEN250009.

How long did the DEN250009 review take?

FDA received the submission on Mar 31, 2025 and issued its decision on Jan 15, 2026, 290 days later.

← All decisions in January 2026