Celerity 20 HP Biological Indicator
K-Number: K252680 · 2025-09-24
ApplicantSTERIS Corporation
Decision Date2025-09-24
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Celerity 20 HP Biological Indicator is a medical device manufactured by STERIS Corporation. It received FDA 510(k) clearance on 2025-09-24 under approval number K252680. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Celerity 20 HP Biological Indicator?
Celerity 20 HP Biological Indicator is a medical device that received FDA 510(k) clearance on 2025-09-24. It is manufactured by STERIS Corporation. The 510(k) number is K252680.
When was Celerity 20 HP Biological Indicator approved by the FDA?
Celerity 20 HP Biological Indicator received FDA 510(k) clearance on 2025-09-24, under approval number K252680.
What company makes Celerity 20 HP Biological Indicator?
Celerity 20 HP Biological Indicator is manufactured by STERIS Corporation.
What is the FDA product code for Celerity 20 HP Biological Indicator?
The FDA product code for Celerity 20 HP Biological Indicator is FRC.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.