510(k) Report

Devices descending from K042116

36 later devices reach Sterrad NX Sterilizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162007STERRAD NX SterilizerAdvanced Sterilization Products20170—
+1K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products20161—
+1K142454STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products201592
+1K102330Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation201121—
+1K071385Sterrad 100NX SterilizerAdvanced Sterilization Products2007195
+2K231893LOWTEM Crystal 120Lowtem Co., Ltd.20240—
+2K220404STERRAD NX with ALLClear TechnologyAdvanced Sterilization Products, Inc.20220—
+2K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products20164—
+2K151725STERRAD NX Sterilizer, STERRAD 100NX SterilizerAdvanced Sterilization Products201611
+2K131120Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation201316—
+2K111377Sterrad (R) 100NX Sterilizer Duo CycleAdvanced Sterilization Products2012171
+2K120632Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization SystemSTERIS Corporation201217—
+2K112813Amsco V-ProSteris Corp20110—
+2K112760Amsco V-Pro Max Low Temperature Sterilization SystemSTERIS Corporation201118—
+2K092622Sterrad 100NX Sterilizer Express CycleAdvanced Sterilization Products201110—
+3K233762SteroScope® Sterilization Technology SystemIdeate Medical, Inc.20240—
+3K212174STERRAD 100NX Sterilizer with ALLClear TechnologyAdvanced Sterilization Products, Inc.20213—
+3K160433V-PRO® 1 Plus and V-PRO® maX Low TemperatureSTERIS Corporation20168—
+3K141163Sterizone SterilizerTso3, Inc.20145—
+3K140498V-Pro 60 Low Temperature Sterilization SystemSTERIS Corporation20140—
+4K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104)…Advanced Sterilization Products20242—
+4K172191STERIZONE VP4 SterilizerTso3, Inc.20180—
+4K162413AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…STERIS Corporation201771
+4K153689STERIZONE SterilizerTso3, Inc.20162—
+4K153392STERIZONE VP4 SterilizerTs03, Inc.20164—
+5K250802STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104)Advanced Sterilization Products, Inc.20251—
+5K173694STERIZONE VP4 SterilizerTso3, Inc.20181—
+5K172754V-PRO maX 2 Low Temperature Sterilization SystemSTERIS Corporation20180—
+5K172319AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature…STERIS Corporation201851
+6K252843STERRAD 100NX Sterilization System with ALLClear Technology (10104)Advanced Sterilization Products, Inc.20260—
+6K190260STERIZONE (R) VP4 SterilizerTso3, Inc.20190—
+6K182568V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization…STERIS Corporation20194—
+7K190027SteriStayToul Meditech AB20190—
+7K190917V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization…STERIS Corporation20192—
+8K222849AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20220—
+8K222543AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2…Steris20221—