510(k) Report

Devices descending from K011679

8 later devices reach Fertilmarq Home Diagnostic Screening Test Kit for Male Infertility through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100341Spermcheck FertilityPrinceton BioMeditech Corp.20104—
+1K073039Spermcheck VasectomyPrinceton BioMeditech Corp.20085—
+1K041039Fertell Male Fertility TestGenosis, Ltd.20047—
+2K183602SwimCount Sperm Quality TestMotilitycount Aps20190—
+2K161493YO Home Sperm TestMedical Electronic Systems, Ltd.20161—
+2K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc.20161—
+3K241628YO Home Sperm TestMedical Electronic Systems, Ltd.20240—
+3K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc.20170—