510(k) Report

Devices descending from K990941

11 later devices reach Newlife Dish (Etched or Non-Etched, with or Without Lid), Models 14-52, 1452E… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090429Nunc Ivf Centerwell and Icsi DishesThermo Fisher Scientific (Nalge Nunc Intl)200910—
+2K123641Culture Dish 40 MM, Culture Dish 60 MM, Micro Droplet Culture Dish, 5 Well Culture Dish…Hertart20131—
+2K112413RI MSC (Migration Sedimentation Chamber)Research Instruments, Ltd.20127—
+3K150756Micro well group culture dish, 9-well; Micro well group culture dish, 16-wellHertart20150—
+3K133295QualisMenicon Co., Ltd. New Business Division20145—
+3K112644Seaforia Sperm Separation Assistance SystemLotus Bio, Ltd.20120—
+4K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc.20184—
+5K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation20250—
+5K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps20250—
+5K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.20240—
+5K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceBonraybio Co., Ltd.20220—