510(k) Report

Devices descending from K100341

4 later devices reach Spermcheck Fertility through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161493YO Home Sperm TestMedical Electronic Systems, Ltd.20161—
+1K153683Trak Male Fertility Testing SystemSandstone Diagnostics, Inc.20161—
+2K241628YO Home Sperm TestMedical Electronic Systems, Ltd.20240—
+2K172514Trak Plus Male Fertility Testing SystemSandstone Diagnostics, Inc.20170—