510(k) Report

Devices descending from K071014

42 later devices reach Modification to Sterrad Cyclesure Biological Indicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103222Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products2011204
+1K102884Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products201120—
+1K090514Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization ProcessesSTERIS Corporation20094—
+1K073244Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization ProcessesSTERIS Corporation200820—
+2K141580Sterizone Self-Contained Biological IndicatorTso3, Inc.20141—
+2K141238Sterilucent Self-Contained Biological IndicatorSterilucent, Inc.20140—
+2K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSTERIS Corporation201414—
+2K140708Verify V24 Self-Contained Biological IndicatorSTERIS Corporation20141—
+2K122044Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products20120—
+2K111375Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products201218—
+3K203560STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker20210—
+3K173488CELERITY 20 HP Challenge PackSTERIS Corporation20188—
+3K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…Steris Corporations20183—
+3K172474Celerity 20 HP Biological IndicatorSTERIS Corporation20170—
+3K171504VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation201791
+3K123017Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products201217—
+4K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation20233—
+4K220473CELERITY 20 HP Challenge PackSteris20220—
+4K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…Steris Corporations20192—
+4K183294CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation20196—
+4K172752CELERITY 20 HP Biological IndicatorSTERIS Corporation20188—
+4K151971STERRAD CYCLESURE 24 Biological IndicatorAdvanced Sterilization Products20155—
+4K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company201412—
+5K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation20260—
+5K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…STERIS Corporation20251—
+5K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological IndicatorSTERIS Corporation20231—
+5K181429CELERITY 20 HP Biological IndicatorSTERIS Corporation20180—
+5K171287Sporview VH202 BISpsmedical Supply Corp. A Division of Cantel Medical20180—
+5K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company20175—
+5K170039STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp)20173—
+5K1520603M Attest Rapid Readout Biological Indicator 12953M Company201511—
+6K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation20250—
+6K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…Steris20250—
+6K182404STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp)20182—
+6K1734353M Attest Rapid Readout Biological Indicator3M Company20184—
+6K1605463M Attest Rapid Readout Biological Indicator3M Company20166—
+7K2009963M Attest Rapid Readout Biological Indicator3M Company20203—
+7K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderAdvanced Sterilization Products (Asp)20201—
+8K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…Advanced Sterilization Products, Inc.20240—
+8K2102773M Attest Rapid Readout Biological Indicator, 12953M Company20212—
+9K2117053M Attest Rapid Readout Biological Indicator, 12953M Company20221—
+10K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen…3M Company20240—