510(k) Report

Devices descending from K072609

9 later devices reach Single Step Medium through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121572Continuous Single Culture CompleteIrvine Scientific Sales Co., Inc.20128—
+2K170681Continuous Single Culture -NX (CSCM-NX)Irvine Scientific Sales Co., Inc.20171—
+2K170602Continuous Single Culture-NX Complete (CSCM-NXC)Irvine Scientific Sales Co., Inc.20170—
+2K133568G-TLVitrolife, Inc.20144—
+3K202862Gx-IVF, Gx-TL, Gx-MOPS PLUSVitrolife Sweden AB20210—
+3K193522iMedium Single Step; iMedium Single Step with HSA; iMedium Single Step with rHAKitazato Corporation20200—
+3K1910631-Step Culture MediumShenzhen Vitavitro Biotech Co., Ltd.20191—
+3K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst…Genea Biomedx Pty, Ltd.20170—
+4K193285V-OnestepVitromed GmbH20200—