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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 / June 2026 / K261055

510(k) cleared

AMSCO 700 Steam Sterilizer

STERIS Corporation · Jun 24, 2026 · K261055

FDA cleared the AMSCO 700 Steam Sterilizer from STERIS Corporation on Jun 24, 2026 under K261055, 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 Mar 31, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

STERIS Corporation has 4 other decisions in the tracker over the last 12 months: DEN240075 (Prolystica Pass Thru Disinfectant Wipes), K251666 (SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900), K260766 (Celerity 5 HP Biological Indicator (LCB052)), K252680 (Celerity 20 HP Biological Indicator).

Questions & Answers

What did FDA clear under K261055?

K261055 is the FDA 510(k) for AMSCO 700 Steam Sterilizer, submitted by STERIS Corporation. FDA's decision date was Jun 24, 2026, under product code FLE (Sterilizer, Steam).

Who makes the AMSCO 700 Steam Sterilizer?

STERIS Corporation, based in Mentor, OH, is the applicant of record for K261055.

How long did the K261055 review take?

FDA received the submission on Mar 31, 2026 and issued its decision on Jun 24, 2026, 85 days later.

← All decisions in June 2026