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FDA 510(k)

CELERITY 20 HP Challenge Pack

K-Number: K220473 · 2022-03-18

ApplicantSteris
Decision Date2022-03-18
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CELERITY 20 HP Challenge Pack is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K220473. 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 Challenge Pack?

CELERITY 20 HP Challenge Pack is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Steris. The 510(k) number is K220473.

When did CELERITY 20 HP Challenge Pack receive FDA 510(k) clearance?

CELERITY 20 HP Challenge Pack received FDA 510(k) clearance on 2022-03-18, under 510(k) number K220473.

Who is the listed applicant for CELERITY 20 HP Challenge Pack?

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

What is the FDA product code for CELERITY 20 HP Challenge Pack?

The FDA product code for CELERITY 20 HP Challenge Pack is FRC.

Other records listing Steris 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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