510(k) Report

Devices descending from K112413

7 later devices reach RI MSC (Migration Sedimentation Chamber) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133295QualisMenicon Co., Ltd. New Business Division20145—
+1K112644Seaforia Sperm Separation Assistance SystemLotus Bio, Ltd.20120—
+2K173075ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)Dxnow, Inc.20184—
+3K241626SperSort™ Sperm Sorting Chip (IPG02)Ipreg Incorporation20250—
+3K241348SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)Motilitycount Aps20250—
+3K232980SpermAlign Sperm Separation DeviceCytoswim, Ltd.20240—
+3K221810LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation DeviceBonraybio Co., Ltd.20220—