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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 / K252843

510(k) cleared

STERRAD 100NX Sterilization System with ALLClear Technology (10104)

Advanced Sterilization Products, Inc. · Apr 15, 2026 · K252843

FDA cleared the STERRAD 100NX Sterilization System with ALLClear Technology (10104) from Advanced Sterilization Products, Inc. on Apr 15, 2026 under K252843, a traditional 510(k). The device falls under product code MLR, Sterilizer, Chemical, regulated at 21 CFR 880.6860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 8, 2025. The decision came 219 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 Advanced Sterilization Products, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252843?

K252843 is the FDA 510(k) for STERRAD 100NX Sterilization System with ALLClear Technology (10104), submitted by Advanced Sterilization Products, Inc.. FDA's decision date was Apr 15, 2026, under product code MLR (Sterilizer, Chemical).

Who makes the STERRAD 100NX Sterilization System with ALLClear Technology (10104)?

Advanced Sterilization Products, Inc., based in Irvin, CA, is the applicant of record for K252843.

How long did the K252843 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Apr 15, 2026, 219 days later.

← All decisions in April 2026