510(k) Report

Devices descending from K133295

5 later devices reach Qualis through their predicates, nearest generation first.

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