510(k) Report

Devices descending from K990189

19 later devices reach Modification of: Midmark M-11 Ultraclave Steam Sterilizer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181993STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R)Sturdy Industrial Co., Ltd.20191—
+1K163337Midmark and Ritter M9 and M11 UltraClave® Automatic Sterilizers and Ritter M9D…Midmark Corporation20171—
+1K023348Midmark M9 Ultraclave Steam SterilizerMidmark Corp.200313—
+1K021064Quantim 16 AutoclaveScican20020—
+1K992744Midmark M4*9 Easyclave Steam SterilizerMidmark Corp.20001—
+2K233026Midmark Smart M9® Sterilizer, Midmark Smart M11® SterilizerMidmark Corporation20240—
+2K231489Sturdy Autoclave Super MicromSturdy Industrial Co., Ltd.20230—
+2K063681Tecno-Gaz Andromeda Vacuum CS AutoclaveMediline Italia S.R.L.20070—
+2K050263Millennium Series, Including Millennium B, B+, B2 and BUM.O. Com S.R.L.20068—
+2K052532Imax 9.5 SterilizersDental X Srl20060—
+2K024133CLS-2000 UnitDentsply Intl.20030—
+3K151597Family of Steam Sterilizers B 28 seriesCefla S.C.20161—
+3K143311Pre-vacuum Tabletop AutoclaveTuttnauer U.S.A Co, Ltd.20156—
+3K090265Bravo Autoclave, Models 17, 17V and 21VScican, Ltd.20090—
+4K222608Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WSTuttnauer, Ltd.20220—
+4K213080T-Edge 10, T-Edge 11Tuttnauer, Ltd.20222—
+4K161848Family of Steam sterilizers B17 B22 SeriesCefla S.C.20170—
+5K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd.20231—
+6K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare20250—