ClearanceBrief
510(k) K083665 ยท FRC Indicator, Biological Sterilization Process

VERIFY SCBI 275F 3-10

ApplicantSTERIS Corporation, Mentor OH, US
DecisionSubstantially Equivalent, Sep 1, 2009
ReceivedDec 10, 2008
TypeAbbreviated
FDA recordOpen on fda.gov

Recalls that name K083665

DateFirm and productCodeLinked 510(k)
Oct 2, 2026Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3060
Open, Classified		 FRCNone listed
Oct 2, 2026Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator Model/Catalog Number: S3061
Open, Classified		 FRCNone listed
Jan 3, 2023Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization proce
Open, Classified		 FRCNone listed
Jan 3, 2023Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization proc
Open, Classified		 FRCNone listed
Jan 3, 2023Steris Corporation
VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Open, Classified		 FRCNone listed
Jan 3, 2023Steris Corporation
VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Open, Classified		 FRCNone listed
Dec 28, 2013Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethy
Terminated		 FRCNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.