510(k) Report

Devices descending from K032155

20 later devices reach G-Thawkit Blast through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K073522Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc.200819—
+2K170560SAGE Vitrification Kit and SAGE Vitrification Warming KitCooperSurgical, Inc.20170—
+2K093273Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc.201017—
+3K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd.20161—
+3K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…Irvine Scientific2016142
+4K183486RapidVit™ Oocyte, RapidWarm™ OocyteVitrolife Sweden AB20190—
+4K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc.20192—
+4K180073Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw SetShenzhen Vitavitro Bio-Tech Co., Ltd.20180—
+4K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit…CooperSurgical, Inc.20181—
+4K171748Vitrification Kit and Thawing KitKitazato Corporation20177—
+5K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)Cell Store (Beijing) Biotechnology CO., LTD.20260—
+5K250445Fast Warm - NXFujifilm Irvine Scientific20250—
+5K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation20251—
+5K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)Donnevie Medical Technology (Shanghai) Co., Ltd.20250—
+5K242089Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)Jiangsu Ruifuda Medical Device Co., Ltd.20250—
+5K240176V-VITFREEZE and V-VITWARMVitromed GmbH20240—
+5K233846Vitrification Solution Set and Warming Solution SetEcmpc, LLC20240—
+5K233477Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML…Shandong Wego Ruisheng Medical Device Co., Ltd.20240—
+5K223265CryoX Vitrification Freeze Kit / Thaw KitZhejiang Horizon Medical Technology Co., Ltd.20230—
+6K260248Ultra-Fast WarmKitazato Corporation20260—