ClearanceBrief
510(k) K854902 ยท FRC Indicator, Biological Sterilization Process

SURGICOT STEAM TEST PACK

ApplicantSurgicot, Inc., Smithtown NY, US
DecisionSubstantially Equivalent, May 20, 1986
ReceivedDec 9, 1985
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K854902

DateFirm and productCodeLinked 510(k)
Oct 2, 2026Steris Corporation
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB006
Open, Classified
FRCNone listed
Oct 2, 2026Steris Corporation
VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
Open, Classified
FRCNone listed
Oct 2, 2026Steris Corporation
VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Open, Classified
FRCNone listed
Oct 2, 2026Steris Corporation
VERIFY Biological Steam Test Pack Model/Catalog Number: S3069
Open, Classified
FRCNone listed
Sep 26, 2022Mckesson Medical-Surgical Inc. Corporate Office
a. STERIS CORP Celerity Celerity 20 Sterilization Indicator Challenge Pack Steam 3 Inch Length Model Number: LCB053. b. STERIS CORP VERIFY Verify SixCess Sterilization Flash Indicator Strip Steam 2-3/
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.