510(k) Report

Devices descending from K061767

39 later devices reach Quikclot 1ST Response & Quikclot Acs+ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K070010Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation200738—
+2K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+2K072474Quikclot EXZ-Medica Corporation2007361
+3K211570Zeolite Hemostatic GauzeHangzhou Zeo-Innov Life Technology Co., Ltd.20221—
+3K180893IHM Technology BandageProtege Biomedical20180—
+3K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc.20160—
+3K123387Quikclot Hemostatic DressingZ-Medica, LLC201332
+3K101257Advanced Trauma Dressing (Atd)Nanosys, Inc.20110—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+3K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc.200920—
+3K080648Traumastat Rapid Hemostatic Wound Dressing BandageOre-Medix, LLC20080—
+4K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.20260—
+4K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…Speciality Fibres and Materials Limited20260—
+4K213413Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.20230—
+4K223495Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd.20230—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc.20162—
+4K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+4K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+4K111163Chitogauze FusionHem Con Medical Technologies, Inc.20110—
+4K102546ChitogauzeHem Con Medical Technologies, Inc.20109—
+4K093519Medtrade Products Celox Vascular Topical Hemostatic Granules on SheetMedtrade Products, Ltd.20102—
+4K091795Medtrade Products Celox Trauma GauzeMedtrade Products, Ltd.20097—
+4K092357Chitogauze,2 in X 2 in,8 Ply, 4 in X 4 in 8 Ply, 4 in X 8 in, 8PLY, 1 in X 4 in, 8PLY…Hem Con Medical Technologies, Inc.200910—
+5K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd.20230—
+5K192671Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd.20200—
+5K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+5K181641QuikClot RadialZ-Medica, LLC20180—
+5K142363Nustat, Nustat XRBeeken Biomedical20154—
+5K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+5K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+6K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+6K222189SiOxD Wound MatrixSioxmed, LLC20222—
+6K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+6K160578Nustat XRBeeken Biomedical, LLC20160—
+6K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+7K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+7K232847SiOxD Wound MatrixSioxmed, LLC20231—
+7K222909Axiostat GauzeAdvamedica, Inc.20230—