510(k) Report

Devices descending from K073618

21 later devices reach Verify Sirius Biological Indicator Challenge Pack through their predicates, nearest generation first.

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