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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2025-09-24 under 510(k) 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. The listed applicant is STERIS Corporation. The 510(k) number is K252680.

When did Celerity™ 20 HP Biological Indicator receive FDA 510(k) clearance?

Celerity™ 20 HP Biological Indicator received FDA 510(k) clearance on 2025-09-24, under 510(k) number K252680.

Who is the listed applicant for Celerity™ 20 HP Biological Indicator?

The FDA 510(k) record lists STERIS Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Celerity™ 20 HP Biological Indicator?

The FDA product code for Celerity™ 20 HP Biological Indicator is FRC.

Other records listing STERIS Corporation as applicant

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Related Devices (Code: FRC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260766Celerity 5 HP Biological Indicator (LCB052)STERIS CorporationK251122Terragene® Bionova® BT20 Biological IndicatorTerrageneK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)SterisK250061Celerity IncubatorSTERIS CorporationK250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)STERIS CorporationK2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490M3M Company

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.

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