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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 / May 2026 / DEN240075

510(k) cleared

Prolystica Pass Thru Disinfectant Wipes

Steris · May 1, 2026 · DEN240075

FDA cleared the Prolystica Pass Thru Disinfectant Wipes from Steris on May 1, 2026 under DEN240075, a direct 510(k). The device falls under product code SHM, Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe, regulated at 21 CFR 880.6891 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Dec 12, 2024. The decision came 505 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Steris has 4 other decisions in the tracker over the last 12 months: K261055 (AMSCO 700 Steam Sterilizer), 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 DEN240075?

DEN240075 is the FDA 510(k) for Prolystica Pass Thru Disinfectant Wipes, submitted by Steris. FDA's decision date was May 1, 2026, under product code SHM (Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe).

Who makes the Prolystica Pass Thru Disinfectant Wipes?

Steris, based in Mentor, OH, is the applicant of record for DEN240075.

How long did the DEN240075 review take?

FDA received the submission on Dec 12, 2024 and issued its decision on May 1, 2026, 505 days later.

← All decisions in May 2026