510(k) Report

Devices descending from K190152

2 later devices reach Vit Kit- Freeze NX and Vit Kit- Warm NX through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250445Fast Warm - NXFujifilm Irvine Scientific20250—
+1K223265CryoX Vitrification Freeze Kit / Thaw KitZhejiang Horizon Medical Technology Co., Ltd.20230—