510(k) Report

Devices descending from K920719

10 later devices reach Ivos Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041039Fertell Male Fertility TestGenosis, Ltd.20047—
+1K012805AutomarqerHamilton Thorne Research20020—
+1K990184AutomarqerHamilton Thorne Research19990—
+2K183602SwimCount Sperm Quality TestMotilitycount Aps20190—
+2K100341Spermcheck FertilityPrinceton BioMeditech Corp.20104—
+2K073039Spermcheck VasectomyPrinceton BioMeditech Corp.20085—
+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—