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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 / K251139

510(k) cleared

KabiHelp® Uno; KabiHelp® Advance plus

Fresenius Kabi AG · Jan 9, 2026 · K251139

FDA cleared the KabiHelp® Uno; KabiHelp® Advance plus from Fresenius Kabi AG on Jan 9, 2026 under K251139, a traditional 510(k). The device falls under product code KPE, Container, I.V., regulated at 21 CFR 880.5025 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Apr 14, 2025. The decision came 270 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 Fresenius Kabi AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251139?

K251139 is the FDA 510(k) for KabiHelp® Uno; KabiHelp® Advance plus, submitted by Fresenius Kabi AG. FDA's decision date was Jan 9, 2026, under product code KPE (Container, I.V.).

Who makes the KabiHelp® Uno; KabiHelp® Advance plus?

Fresenius Kabi AG, based in Bad Homburg, is the applicant of record for K251139.

How long did the K251139 review take?

FDA received the submission on Apr 14, 2025 and issued its decision on Jan 9, 2026, 270 days later.

← All decisions in January 2026