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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 / April 2026 / K260766

510(k) cleared

Celerity 5 HP Biological Indicator (LCB052)

STERIS Corporation · Apr 8, 2026 · K260766

FDA cleared the Celerity 5 HP Biological Indicator (LCB052) from STERIS Corporation on Apr 8, 2026 under K260766, a special 510(k). The device falls under product code FRC, Indicator, Biological Sterilization Process, regulated at 21 CFR 880.2800 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 9, 2026. The decision came 30 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: K261055 (AMSCO 700 Steam Sterilizer), 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), K252680 (Celerity 20 HP Biological Indicator).

Questions & Answers

What did FDA clear under K260766?

K260766 is the FDA 510(k) for Celerity 5 HP Biological Indicator (LCB052), submitted by STERIS Corporation. FDA's decision date was Apr 8, 2026, under product code FRC (Indicator, Biological Sterilization Process).

Who makes the Celerity 5 HP Biological Indicator (LCB052)?

STERIS Corporation, based in Mentor, OH, is the applicant of record for K260766.

How long did the K260766 review take?

FDA received the submission on Mar 9, 2026 and issued its decision on Apr 8, 2026, 30 days later.

← All decisions in April 2026