Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CELERITY 20 Steam Biological Indicator

K-Number: K181686 · 2018-07-24

ApplicantSTERIS Corporation
Decision Date2018-07-24
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CELERITY 20 Steam 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 2018-07-24 under 510(k) number K181686. 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 Steam Biological Indicator?

CELERITY 20 Steam Biological Indicator is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is STERIS Corporation. The 510(k) number is K181686.

When did CELERITY 20 Steam Biological Indicator receive FDA 510(k) clearance?

CELERITY 20 Steam Biological Indicator received FDA 510(k) clearance on 2018-07-24, under 510(k) number K181686.

Who is the listed applicant for CELERITY 20 Steam 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 Steam Biological Indicator?

The FDA product code for CELERITY 20 Steam Biological Indicator 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

View all 139 devices →

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.

↑