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FDA 510(k)

Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape

K-Number: K231488 · 2023-08-07

ApplicantSteris
Decision Date2023-08-07
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape is the device name listed in this FDA 510(k) record. The listed applicant is Steris. It received FDA 510(k) clearance on 2023-08-07 under 510(k) number K231488. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape?

Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape is a medical device that received FDA 510(k) clearance on 2023-08-07. The listed applicant is Steris. The 510(k) number is K231488.

When did Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape receive FDA 510(k) clearance?

Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape received FDA 510(k) clearance on 2023-08-07, under 510(k) number K231488.

Who is the listed applicant for Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape?

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™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape?

The FDA product code for Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape is JOJ.

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: JOJ)

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.

K260181LF Process Indicator Tape for Steam SterilizationIntertape Polymer GroupK251991SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure Vaporized Hydrogen Peroxide Sterilization Process Indicator (4211, 4212, 4213)Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA Test StripsSerim ResearchK251048Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118STERIS CorporationK243876VERIFY STEAM Integrating IndicatorSTERIS CorporationK250172Green Card Bowie-Dick Test (BD115)Steritec Products, Inc. (A Getinge 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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