510(k) Report

Devices descending from K181461

3 later devices reach Rapid-i™ Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K200815VitriGuardOrigio A/S20202—
+2K241341cryo-GO Vitrification DeviceFujifilm Irvine Scientific20240—
+2K233177Nest VT Vitrification DeviceCook Incorporated20240—