510(k) Report

Devices descending from K213080

2 later devices reach T-Edge 10, T-Edge 11 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K232658T-Top 10 & T-Top T-Top 11Tuttnauer U.S.A Co, Ltd.20231—
+2K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas Lifecare20250—