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FDA 510(k)

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack

K-Number: K223717 · 2023-06-15

ApplicantSTERIS Corporation
Decision Date2023-06-15
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is STERIS Corporation. It received FDA 510(k) clearance on 2023-06-15 under 510(k) number K223717. 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 5 HP Biological Indicator; Celerity 5 HP Challenge Pack?

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is a medical device that received FDA 510(k) clearance on 2023-06-15. The listed applicant is STERIS Corporation. The 510(k) number is K223717.

When did Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack receive FDA 510(k) clearance?

Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack received FDA 510(k) clearance on 2023-06-15, under 510(k) number K223717.

Who is the listed applicant for Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack?

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 5 HP Biological Indicator; Celerity 5 HP Challenge Pack?

The FDA product code for Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge Pack is FRC.

Other records listing STERIS Corporation as applicant

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.

K261055AMSCO 700 Steam SterilizerK260766Celerity 5 HP Biological Indicator (LCB052)K251666SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700; SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900K252680Celerity™ 20 HP Biological IndicatorK251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP Biological Indicator (LCB044); Celerity 20 HP Challenge Pack (LCB045)K251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118

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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 CorporationK252680Celerity™ 20 HP Biological IndicatorSTERIS 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 Corporation

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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