510(k) Report

Devices descending from K002550

99 later devices reach RDH Bandage through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082703MRDH BandageMarine Polymer Technologies, Inc.20083—
+1K070557MP 719Marine Polymer Technologies, Inc.20072—
+1K023298Hemcon BandageHemcon, Inc.200274—
+1K013390QuickclotOn Site Gas Systems, Inc.200264—
+2K150916HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO…Hem Con Medical Technologies, Inc.20153—
+2K111524MP 719Marine Polymer Technologies, Inc.20110—
+2K103641GuardacareHem Con Medical Technologies, Inc.20112—
+2K102002TalymedMarine Polymer Technologies20100—
+2K080210Pro QR Advanced Formula PowderBiolife, LLC200916—
+2K082601UltraClot, UltraClot OTCEmergency Medical Devices, LLC20080—
+2K072474Quikclot EXZ-Medica Corporation2007361
+2K071936Woundstat, Model TC1001Traumacure, Inc.20073—
+2K070010Quikclot Sport and Quikclot Sport SilverZ-Medica Corporation200738—
+2K060363Hemcon Dental Dressing, 1 Dressing, 4 Dressing, 1 Dressing, Box of 12, 4 Dressing, Box…Hemcon, Inc.20061—
+2K061079Medtrade Products Celox Topical Hemostatic Granules, Medtrade Products Celox 762…Medtrade Products, Ltd.200627—
+2K051955Quickclot Acs - Accelerated Clotting SpongeZ-Medica Corporation200542—
+2K043050Hemcon Bandage and Hemcon Bandage OtcHemcon, Inc.200555—
+2K050769Quikclot Brand Hemostatic Agent - Advanced Beaded Formulation - 100G - 1.9MM - 2.4MM.…Z-Medica Corporation20050—
+2K030946Hemcon Bandage Otc; Hemcon Cath/AidHemcon, Inc.200356—
+3K220525RESPONDER Polysaccharide HemostatStarch Medical, Inc.20231—
+3K210751S.E.A.L. Hemostatic Wound SprayBc3 Technologies, Inc.20230—
+3K221428PerioStom Dental DressingForward Science, LLC20220—
+3K211570Zeolite Hemostatic GauzeHangzhou Zeo-Innov Life Technology Co., Ltd.20221—
+3K202830Axiostat PatchAdvamedica, Inc.20210—
+3K182811gel-e Flex+Gel-E, Inc.20191—
+3K180893IHM Technology BandageProtege Biomedical20180—
+3K153138Cerdak BasicBu Polysciences Equipment & Trading, LLC20170—
+3K160130BloodSTOP iX Battle MatrixLifescience Plus, Inc.20160—
+3K140757D2 Hemostantic DressingZ-Medica, LLC20141—
+3K130324Statseal DiscBiolife, LLC20131—
+3K123387Quikclot Hemostatic DressingZ-Medica, LLC201332
+3K120958Posisep and Posisep X Hemostat DressingsHemostasis, LLC20126—
+3K101257Advanced Trauma Dressing (Atd)Nanosys, Inc.20110—
+3K093593Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Medtrade Products Limited201013—
+3K090780Medtrade Products Celox Topical Hemostatic PasteMedtrade Products, Ltd.20090—
+3K090620Quikclot Inteventional, Model P/N 182Z-Medica Corporation20095—
+3K090026Chitogauze, Models 130, 131, 263, 264, 265, 266Hem Con Medical Technologies, Inc.200920—
+3K072486Modification to Hemcon Bandage and Hemcon Bandage OtcHem Con Medical Technologies, Inc.2008356
+3K080097Medtrade Products Celox Hemostatic Granules on SheetMedtrade Products, Ltd.200818—
+3K081183WoundstatTraumacure, Inc.20081—
+3K080818Hemcon Bandage, Hemcon Bandage Otc, Hemcon Chitoflex-Surgical DressingHem Con Medical Technologies, Inc.200811—
+3K080648Traumastat Rapid Hemostatic Wound Dressing BandageOre-Medix, LLC20080—
+3K072328Medtrade Products Celox Solbag, Anti - CoagulantMedtrade Products, Ltd.20070—
+3K072890Stasilon FREntegrion, Inc.20075—
+3K071519Hemcon Chitoflex-Surgical DressingHemcon, Inc.200722—
+3K061767Quikclot 1ST Response & Quikclot Acs+Z-Medica Corporation200639—
+4K254073StatSeal DiscMerit Medical Systems, Inc.20260—
+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—
+4K243553QuikClot Control+ Hemostatic DeviceTeleflex Medical20250—
+4K240713Traumagel®Cresilon, Inc.20242—
+4K240454RESPONDER® Polysaccharide HemostatStarch Medical, Inc.20240—
+4K213413Hemostatic DressingJiangsu Newvalue Medical Products Co., Ltd.20230—
+4K223495Zeolite Hemostatic CottonHangzhou Zeo-Innov Life Technology Co., Ltd.20230—
+4K192667gel-e Flex+ gel OTCGel-E, Inc.20190—
+4K180152gel-e FlexGel-E, Inc.20182—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K161274Bondiloxs Topical Hemostatic GranulesMedtrade Products, Ltd.20170—
+4K153582Prometheus ChitoGauze XR PROHem Con Medical Technologies, Inc.20162—
+4K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+4K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+4K142363Nustat, Nustat XRBeeken Biomedical20154—
+4K141704Novashield Injectable Nasal Packing and StentMedtronic, Inc.20142—
+4K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+4K132343Marigen Wound DressingKerecis Limited20135—
+4K122494Posisep and Posisep X Hemostat Dressing/Intranasal SplintHemostasis, LLC20132—
+4K120782Interventional Hemostatic BandageZ-Medica Corporation20131—
+4K113560Celox Gauze ProMedtrade Products, Ltd.201211—
+4K111163Chitogauze FusionHem Con Medical Technologies, Inc.20110—
+4K110386Celox Rapid GauzeMedtrade Products, Ltd.20111—
+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—
+5K250319Mfuse (MS001)Machina Medical, Inc.20250—
+5K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—
+5K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+5K230589Celox Rapid X-Ray GauzeMedtrade Products, Ltd.20230—
+5K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)Cresilon, Inc.20231—
+5K222909Axiostat GauzeAdvamedica, Inc.20230—
+5K222189SiOxD Wound MatrixSioxmed, LLC20222—
+5K192671Hemostatic Xerogel SpongeSolaplus Biotech Co., Ltd.20200—
+5K190012OMNI-STAT Vascular (Rapid); CELOX Vascular RapidMedtrade Product, Ltd.20190—
+5K190528MariGen Wound ExtraKerecis Limited20193—
+5K181641QuikClot RadialZ-Medica, LLC20180—
+5K181696ChitoZolveGyrus Acmi, Inc.20180—
+5K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—
+5K172179Chitogel Endoscopic Sinus Surgery KitChitogel, Ltd.20171—
+5K153364Kerecis SecureMeshKerecis Limited20160—
+5K160578Nustat XRBeeken Biomedical, LLC20160—
+5K141816HemoporePolyganics B.V.,20140—
+5K132333Bondiloxs Topical Hemostatic DressingMedtrade Products, Ltd.20140—
+5K102965Celox Trauma Gauze AG, Celox Hemostatic Antibacterial Trauma Gauze, Omni-Stat Trauma…Medtrade Products, Ltd.20100—
+6K251845Marigen Wound Extra; Kerecis Silicone; Kerecis ParvusKerecis Limited20250—
+6K241080Kerecis Parvus (50207)Kerecis Limited20241—
+6K241660SiOxD® Wound MatrixSioxmed, LLC20240—
+6K232847SiOxD Wound MatrixSioxmed, LLC20231—
+6K230142Epi-Stop Nasal Gel/epistaxis packBiomed Ent, Inc.20230—
+6K213231Kerecis SiliconeKerecis Limited20221—