510(k) Report

Devices descending from K080210

16 later devices reach Pro QR Advanced Formula Powder 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—
+2K254073StatSeal DiscMerit Medical Systems, Inc.20260—
+2K240713Traumagel®Cresilon, Inc.20242—
+2K161274Bondiloxs Topical Hemostatic GranulesMedtrade Products, Ltd.20170—
+2K113560Celox Gauze ProMedtrade Products, Ltd.201211—
+3K250319Mfuse (MS001)Machina Medical, Inc.20250—
+3K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.20250—
+3K151204HEMO-BandageCoreleader Biotech Co., Ltd.20150—
+3K143462AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)Benq Materials Corporation20152—
+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—
+4K232216Hemoblock_S (Prescription); Hemoblock_S (OTC)Incore Co., Ltd.20240—
+4K222909Axiostat GauzeAdvamedica, Inc.20230—
+4K172155StatGuard Hemostatic Patch, StatGuard Hemostatic DressingStatguard, LLC20180—
+4K172324Axiostat Chitosan Hemostatic DressingAdvamedica, Inc.20180—