510(k) Report

Devices descending from K012573

21 later devices reach Castle 400HC/500HC Series Steam Sterilizer, Models 422HC, 433HC, 522HC, and… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K103504Getinge 400HC/500HC Series Steam SterilizerGetinge Sourcing, LLC20113—
+1K070657Getinge 633HC Series Vacuum/Gravity Steam SterilizerGetinge Sourcing, LLC20075—
+1K030789Amsco Century Steam SterilizerSTERIS Corporation20038—
+1K020590Model 733HC Gravity/Vacuum Steam SterilizerGetinge/Castle, Inc.20021—
+2K172159Getinge GSS67N Series Steam SterilizerMaquet GmbH20183—
+2K141009Fort Defiance Automated Steam SterilizerFort Defiance Industries, Inc.201403
+2K120532Getinge 633HC Steam Sterilizer Air Glide SystemGetinge Sourcing, LLC20130—
+2K122071Getinge 400HC-E / Series Steam SterilizerGetinge Sourcing, LLC20130—
+2K120441Getinge 700HC-E Series Steam SterilizerGetinge Sourcing, LLC20122—
+2K120149Skyron Integrity 215 Steam Sterilizer Skytron Integrity 215 SG Steam Sterilizer Sakura…Sakura Seiki Co., Ltd.20122—
+2K111223Amsco Chimeron Small Steam SterilizerSTERIS Corporation201133
+2K031259Model 833HC Vacuum/Gravity Steam SterilizerGetinge USA, Inc.20030—
+3K252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)20260—
+3K221474PRIMUS Healthcare Sterilizer (Model PSS11-HC)Primus Sterilizer Company, LLC20231—
+3K212424AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam SterilizersSTERIS Corporation20210—
+3K201927Getinge GSS610N Series Steam SterilizerMaquet GmbH20211—
+3K132439Sakura Steam Sterilizer Assr; -AO12, -A012W, -AO12P,-AO12PW / Skytron Integrity…Sakura Seiki Co., Ltd.201401
+3K122625Getinge 800HC- Series Steam SterilizerGetinge Sourcing, LLC20130—
+3K122774Sakura Steam Sterilizaer Model Assv-AH06; Sakura Steam Sterilizer Model Assv-AH06E…Sakura Seiki Co., Ltd.20130—
+4K233132PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB)Primus Sterilizer Company, LLC20230—
+4K214120GSS610N21 Series Steam SterilizerMaquet GmbH20220—