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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 / K254305

510(k) cleared

BAROguard Donor Lung Preservation System

Paragonix Technologies, Inc. · Jan 30, 2026 · K254305

FDA cleared the BAROguard Donor Lung Preservation System from Paragonix Technologies, Inc. on Jan 30, 2026 under K254305, a special 510(k). The device falls under product code KDN, System, Perfusion, Kidney, regulated at 21 CFR 876.5880 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Dec 31, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Paragonix Technologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254305?

K254305 is the FDA 510(k) for BAROguard Donor Lung Preservation System, submitted by Paragonix Technologies, Inc.. FDA's decision date was Jan 30, 2026, under product code KDN (System, Perfusion, Kidney).

Who makes the BAROguard Donor Lung Preservation System?

Paragonix Technologies, Inc., based in Waltham, MA, is the applicant of record for K254305.

How long did the K254305 review take?

FDA received the submission on Dec 31, 2025 and issued its decision on Jan 30, 2026, 30 days later.

← All decisions in January 2026