510(k) Report

Devices descending from K042450

24 later devices reach Sterrad NX Challenge Pack through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051643Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products200523—
+2K130263Sterrad 50/100S/200 Test PackAdvanced Sterilization Products20140—
+2K073618Verify Sirius Biological Indicator Challenge PackSTERIS Corporation200921—
+3K092906Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSTERIS Corporation200920—
+4K141312Sterilucent Process Challenge DeviceSterilucent, Inc.20143—
+4K103331Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization ProcessesSTERIS Corporation201115—
+5K192001Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process…Sterilucent, Inc.20192—
+5K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSTERIS Corporation201414—
+6K2338143M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M™…3M Company20241—
+6K173488CELERITY 20 HP Challenge PackSTERIS Corporation20188—
+6K172748VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…Steris Corporations20183—
+6K171504VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation201791
+7K2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)3M Company20240—
+7K223717Celerity 5 HP Biological Indicator; Celerity 5 HP Challenge PackSTERIS Corporation20233—
+7K220473CELERITY 20 HP Challenge PackSteris20220—
+7K183300VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator…Steris Corporations20192—
+7K183294CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation20196—
+7K172752CELERITY 20 HP Biological IndicatorSTERIS Corporation20188—
+8K260766Celerity 5 HP Biological Indicator (LCB052)STERIS Corporation20260—
+8K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…STERIS Corporation20251—
+8K231490Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological IndicatorSTERIS Corporation20231—
+8K181429CELERITY 20 HP Biological IndicatorSTERIS Corporation20180—
+9K252680Celerity™ 20 HP Biological IndicatorSTERIS Corporation20250—
+9K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…Steris20250—