510(k) Report

Devices descending from K921910

42 later devices reach Sterrad Chemical Indicator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103210Tyvek Self-Seal Pouches with Sterrad, Tyvek Rolls with Sterrad, Tyvek Heat-Seal with…Advanced Sterilization Products201115—
+1K103218Sterrad Chemical Indicator StripAdvanced Sterilization Products20112—
+1K030680Spsmedical Gas Plasma Chemical IndicatorSpsmedical Supply Corp.20036—
+1K0132283M Comply 1248 Gas Plasma Chemical IndicatorMinnesota Mining and Mfg. Co.2002141
+1K972300Cross-Checks PSteritec Products Mfg Co, Inc.199801
+2K1506223M Comply Hydrogen Peroxide Chemical Indicator 12483M Company201513—
+2K133838Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corp.201510—
+2K123162U&U Hydrogen Peroxide Gas Plasma Sterilization Pouch/RollU&U Medical Technology Co, Ltd.20140—
+2K112087Tyvek Self-Seal Pouches ,Tyvek Heat-Seal RollsAdvanced Sterilization Products20122—
+2K111518Sterrad Chemial Indicator Strip Model 14100Advanced Sterilization Products20121—
+2K110152Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp.20114—
+2K090650Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsSpsmedical Supply Corp.20095—
+3K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…Advanced Sterilization Products, Inc.20240—
+3K191999Sterilucent VH2O2 Chemical IndicatorsSterilucent, Inc.20190—
+3K180672Sterilization Pouch/Roll Made with TyvekSigma Medical Supplies Corporation20189—
+3K1703213M Comply Hydrogen Peroxide Chemical Indicator 12483M Company201712—
+3K141693Tyvek® Pouch/Roll with STERRAD® Chemical IndicatorAdvanced Sterilization Products201411
+3K140566Spsmedical VH2O2 Indicator Strips, Indicator Labels, Indicator TapeCrosstex International20143—
+4K241123Perpak™ Sterilization Tyvek PouchKm Corp.20240—
+4K221379Steriking LT-Blueline Pouches with TyvekWipak OY20231—
+4K221377SteriKing LT-Blueline Pouches with TyvekWipak OY20221—
+4K212198Tyvek (R) Roll with CI for STERLINKTM SterilizerPlasmapp Co,., Ltd.20213—
+4K200096Crosstex VH2O2 Chemical IndicatorsCrosstex International, Inc. (A Cantel Medical Company)20210—
+4K1832113M Comply Hydrogen Peroxide Chemical Indicator3M Company201911—
+4K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD…Advanced Sterilization Products20170—
+4K143520SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External…Crosstex20150—
+5K231999Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+5K231996Steriking® LT-Blueline Pouches with Tyvek®Wipak OY20230—
+5K231169STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+5K223025Tyvek Roll with CI for STERLINK SterilizerPlasmapp Co,., Ltd.20230—
+5K220345STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK…Plasmapp Co,., Ltd.20230—
+5K1931103M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Healthcare202071
+5K1929373M Comply Hydrogen Peroxide Chemical Indicator3M Company20192—
+6K2034583M Comply Hydrogen Peroxide Chemical Indicator 12483M Company20201—
+6K2032843M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator3M Company20206—
+7K2225083M™ Comply™ Hydrogen Peroxide Chemical Indicator 12483M Company20220—
+7K2120223M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E3M Company20221—
+7K213262CELERITY HP Chemical IndicatorSTERIS Corporation20223—
+8K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen…3M Company20240—
+8K231488Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY…Steris20232—
+9K240760CELERITY HP Indicator TapeSteris20241—
+10K242189CELERITY HP Indicator Tape (PCC077)Steris20240—