510(k) Report

Devices descending from K061219

13 later devices reach D-Stat Dry Hemostatic Bandage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc.20110—
+1K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+1K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+1K072890Stasilon FREntegrion, Inc.20075—
+2K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+2K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+2K142363Nustat, Nustat XRBeeken Biomedical20154—
+2K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+3K222189SiOxD Wound MatrixSioxmed, LLC20222—
+3K181641QuikClot RadialZ-Medica, LLC20180—
+3K160578Nustat XRBeeken Biomedical, LLC20160—
+4K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+4K232847SiOxD Wound MatrixSioxmed, LLC20231—