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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 / December 2025 / K250168

510(k) cleared

Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer

Lucas Lifecare · Dec 30, 2025 · K250168

FDA cleared the Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer from Lucas Lifecare on Dec 30, 2025 under K250168, a traditional 510(k). The device falls under product code FLE, Sterilizer, Steam, regulated at 21 CFR 880.6880 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Jan 21, 2025. The decision came 343 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 Lucas Lifecare in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250168?

K250168 is the FDA 510(k) for Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer, submitted by Lucas Lifecare. FDA's decision date was Dec 30, 2025, under product code FLE (Sterilizer, Steam).

Who makes the Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer?

Lucas Lifecare, based in Janesville, WI, is the applicant of record for K250168.

How long did the K250168 review take?

FDA received the submission on Jan 21, 2025 and issued its decision on Dec 30, 2025, 343 days later.

← All decisions in December 2025