WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / K251666

510(k) cleared

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900

STERIS Corporation · Apr 8, 2026 · K251666

FDA cleared the SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 from STERIS Corporation on Apr 8, 2026 under K251666, a traditional 510(k). The device falls under product code MED, Sterilant, Medical Devices, regulated at 21 CFR 880.6885 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 30, 2025. The decision came 313 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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), K260766 (Celerity 5 HP Biological Indicator (LCB052)), K252680 (Celerity 20 HP Biological Indicator).

Questions & Answers

What did FDA clear under K251666?

K251666 is the FDA 510(k) for SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, submitted by STERIS Corporation. FDA's decision date was Apr 8, 2026, under product code MED (Sterilant, Medical Devices).

Who makes the SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900?

STERIS Corporation, based in Mentor, OH, is the applicant of record for K251666.

How long did the K251666 review take?

FDA received the submission on May 30, 2025 and issued its decision on Apr 8, 2026, 313 days later.

← All decisions in April 2026

Sources