510(k) Report

Devices descending from K070520

17 later devices reach Pro QR (Quick Relief) Powder (for Minor External Bleeding From Wounds &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080210Pro QR Advanced Formula PowderBiolife, LLC200916—
+2K130324Statseal DiscBiolife, LLC20131—
+2K093593Celox Pro, Celox Pro Otc, Celox Hemostatic Granules, Celox Pro Hemostatic Granules, Omni…Medtrade Products Limited201013—
+3K254073StatSeal DiscMerit Medical Systems, Inc.20260—
+3K240713Traumagel®Cresilon, Inc.20242—
+3K161274Bondiloxs Topical Hemostatic GranulesMedtrade Products, Ltd.20170—
+3K113560Celox Gauze ProMedtrade Products, Ltd.201211—
+4K250319Mfuse (MS001)Machina Medical, Inc.20250—
+4K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—
+4K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+4K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+4K132333Bondiloxs Topical Hemostatic DressingMedtrade Products, Ltd.20140—
+4K133121Chito-Sam 100,4IN X4IN,Chito-Sam, 3IN X6FT, Chito-Sam 100,3IN X10FT, Chito-Sam Active…Sam Medical Products20145—
+5K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+5K222909Axiostat GauzeAdvamedica, Inc.20230—
+5K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+5K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—