510(k) Report

Devices descending from K983642

14 later devices reach Cook Mini-Incubator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121566Planer BT37 IncubatorPlaner Plc201212
+1K092183Embryoscope and EmbryoslideUnisense Fertilitech A/S201111—
+2K191020G210 InviCell Plus with SignipHy pH monitoringCooperSurgical, Inc.20200—
+2K171736Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.20172—
+2K150961EmbryoSlide Culture DishVitrolife A/S20154—
+2K113075Embryo Viewer SoftwareUnisense Fertilitech A/S20118—
+2K111715EmbryoscopeUnisense Fertilitech A/S20119—
+3K180188Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri DishGenea Biomedx Pty, Ltd.20180—
+3K173264EmbryoScope+Vitrolife A/S20183—
+3K180304Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.20180—
+3K133712Embryoviewer SoftwareUnisense Fertilitech A/S20144—
+4K242684Harioculture TL-16 Time-lapse IncubatorHua Yue Medical Technology Co., Ltd.20250—
+4K232493Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004)Wuhan Huchuang Union Technology Co., Ltd.20240—
+4K213869EmbryoSlide+ ic8 dishVitrolife A/S20220—