K220473 - CELERITY 20 HP Challenge Pack
(FDA 510(k) Clearance)

K220473 is an FDA 510(k) clearance for the CELERITY 20 HP Challenge Pack, a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by Steris (Mentor, US). The FDA issued a Cleared decision on March 18, 2022, 28 days after receiving the submission on February 18, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.