Advanced Sterilization Products, Inc. - FDA 510(k) Cleared Devices

Advanced Sterilization Products, Inc. is a leader in sterilization and high-level disinfection solutions for healthcare facilities. The company develops sterilization systems, monitoring devices, and endoscope reprocessing equipment, with a manufacturing facility in Irvine, US.

The company holds 5 FDA 510(k) clearances from 5 total submissions, with all cleared devices classified as General Hospital devices. The regulatory record spans from 2021 to 2026, with the most recent clearance in 2026 demonstrating continued product innovation and market activity.

ASP's cleared portfolio includes the STERRAD® 100NX Sterilization System with ALLClear™ Technology and related sterilization monitoring products. The company specializes in hydrogen peroxide gas plasma sterilization systems and rapid biological indicator technologies for terminal sterilization and sterilization assurance in hospital settings.

Explore the company's device names, product codes, and clearance dates in the database to review specific regulatory submissions and cleared device details.