510(k) Report

Devices descending from K021678

46 later devices reach Hemaderm Cotaining Hemadex Clotting Beads through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130324Statseal DiscBiolife, LLC20131—
+1K093593Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Medtrade Products Limited201013—
+1K080210Pro QR Advanced Formula PowderBiolife, LLC200916—
+1K033291Topseal Hemostatic Dressing, Model 11150Radi Medical Systems AB20040—
+1K033666HemadermMedafor, Inc.200329—
+2K254073StatSeal DiscMerit Medical Systems, Inc.20260—
+2K240713Traumagel®Cresilon, Inc.20242—
+2K161274Bondiloxs Topical Hemostatic GranulesMedtrade Products, Ltd.20170—
+2K122886Nexstat Plus and Nexfoam Plus Topical Hemostat DressingHemostasis, LLC20120—
+2K113560Celox Gauze ProMedtrade Products, Ltd.201211—
+2K102459Nexstat (TM) Topical Hemostat Powder; Nexfoam (R) Topical SpongeHemostasis, LLC20109—
+2K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+2K070211Traumarrest and Bleedarrest Hemostatic Particles and FoamHemostasis, LLC200728—
+3K250319Mfuse (MS001)Machina Medical, Inc.20250—
+3K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—
+3K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+3K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+3K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+3K140313Stopsbleeding Topical Hemostat Powder and FoamCoag Medical, LLC20141—
+3K132333Bondiloxs Topical Hemostatic DressingMedtrade Products, Ltd.20140—
+3K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+3K132105Perclot TopicalCryolife, Inc.20140—
+3K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+3K102742Nasal CeaseCatalina, Inc.20111—
+3K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+3K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+3K072900Excelarrest FoamHemostasis, LLC200719—
+4K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.20240—
+4K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+4K222909Axiostat GauzeAdvamedica, Inc.20230—
+4K202830Axiostat PatchAdvamedica, Inc.20210—
+4K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+4K183622NasalCEASE and BleedCEASELes Laboratoires Brothier S.A.20190—
+4K182811gel-e Flex+Gel-E, Inc.20191—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+4K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+4K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+4K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+5K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+5K181641QuikClot RadialZ-Medica, LLC20180—
+5K181696ChitoZolveGyrus Acmi, Inc.20180—
+5K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+5K141816HemoporePolyganics B.V.,20140—
+6K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—