510(k) Report

Devices descending from K140207

4 later devices reach Rapid-I Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181461Rapid-i™ KitVitrolife Sweden AB20193—
+2K200815VitriGuardOrigio A/S20202—
+3K241341cryo-GO Vitrification DeviceFujifilm Irvine Scientific20240—
+3K233177Nest VT Vitrification DeviceCook Incorporated20240—