510(k) Report

Devices descending from K915229

10 later devices reach Semen Analysis Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041039Fertell Male Fertility TestGenosis, Ltd.20047—
+1K983473Fertilmarq Test KitEmbryotech Laboratories, Inc.19989—
+2K183602SwimCount Sperm Quality TestMotilitycount Aps20190—
+2K100341Spermcheck FertilityPrinceton BioMeditech Corp.20104—
+2K073039Spermcheck VasectomyPrinceton BioMeditech Corp.20085—
+2K011679Fertilmarq Home Diagnostic Screening Test Kit for Male InfertilityEmbryotech Laboratories, Inc.20018—
+3K161493YO Home Sperm TestMedical Electronic Systems, Ltd.20161—
+3K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc.20161—
+4K241628YO Home Sperm TestMedical Electronic Systems, Ltd.20240—
+4K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc.20170—