510(k) Report

Devices descending from K000309

22 later devices reach Blastocyst Freeze Medium, Blastocyst Thaw Medium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K032154G-Freezekit BlastVitrolife AB200420—
+1K032155G-Thawkit BlastVitrolife AB200420—
+2K073522Vitrification Kit & Vitrification Warming KitSage In-Vitro Fertilization, Inc.200819—
+3K170560SAGE Vitrification Kit and SAGE Vitrification Warming KitCooperSurgical, Inc.20170—
+3K093273Vit Kit - Freeze and ThawIrvine Scientific Sales Co., Inc.201017—
+4K160864Cryotop Vitrification Kit and Cryotop Thawing KitKitazato Biopharma Co., Ltd.20161—
+4K160006Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…Irvine Scientific2016142
+5K183486RapidVit™ Oocyte, RapidWarm™ OocyteVitrolife Sweden AB20190—
+5K190152Vit Kit- Freeze NX and Vit Kit- Warm NXFujifilm Irvine Scientific, Inc.20192—
+5K180073Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw SetShenzhen Vitavitro Bio-Tech Co., Ltd.20180—
+5K173731SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit…CooperSurgical, Inc.20181—
+5K171748Vitrification Kit and Thawing KitKitazato Corporation20177—
+6K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)Cell Store (Beijing) Biotechnology CO., LTD.20260—
+6K250445Fast Warm - NXFujifilm Irvine Scientific20250—
+6K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation20251—
+6K242561Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit)Donnevie Medical Technology (Shanghai) Co., Ltd.20250—
+6K242089Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202)Jiangsu Ruifuda Medical Device Co., Ltd.20250—
+6K240176V-VITFREEZE and V-VITWARMVitromed GmbH20240—
+6K233846Vitrification Solution Set and Warming Solution SetEcmpc, LLC20240—
+6K233477Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML…Shandong Wego Ruisheng Medical Device Co., Ltd.20240—
+6K223265CryoX Vitrification Freeze Kit / Thaw KitZhejiang Horizon Medical Technology Co., Ltd.20230—
+7K260248Ultra-Fast WarmKitazato Corporation20260—