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FDA 510(k)

SporView Rapid Read Biological Indicator SteamPlus Test Pack

K-Number: K181434 · 2018-11-14

ApplicantCrosstex/Spsmedical, A Division of Cantel Medical
Decision Date2018-11-14
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SporView Rapid Read Biological Indicator SteamPlus Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is Crosstex/Spsmedical, A Division of Cantel Medical. It received FDA 510(k) clearance on 2018-11-14 under 510(k) number K181434. 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 SporView Rapid Read Biological Indicator SteamPlus Test Pack?

SporView Rapid Read Biological Indicator SteamPlus Test Pack is a medical device that received FDA 510(k) clearance on 2018-11-14. The listed applicant is Crosstex/Spsmedical, A Division of Cantel Medical. The 510(k) number is K181434.

When did SporView Rapid Read Biological Indicator SteamPlus Test Pack receive FDA 510(k) clearance?

SporView Rapid Read Biological Indicator SteamPlus Test Pack received FDA 510(k) clearance on 2018-11-14, under 510(k) number K181434.

Who is the listed applicant for SporView Rapid Read Biological Indicator SteamPlus Test Pack?

The FDA 510(k) record lists Crosstex/Spsmedical, A Division of Cantel Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SporView Rapid Read Biological Indicator SteamPlus Test Pack?

The FDA product code for SporView Rapid Read Biological Indicator SteamPlus Test Pack is FRC.

Other records listing Crosstex/Spsmedical, A Division of Cantel Medical 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.

K172432SporView Rapid Read Biological Indicator

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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