510(k) Report

Devices descending from K910657

36 later devices reach Qualtex Island Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K023609Silverlon Adhesive StripArgentum International, LLC200321—
+1K984208Silverlon Island Dressing, Silverlon Island PadArgentum International, LLC199914—
+2K122817Silverlon Island Wound DressingArgentum Medical, LLC201413—
+2K100580Exsalt Wound DressingExciton Technologies, Inc.20100—
+2K082333Asap Wound Dressing GelAmerican Biotech Labs20096—
+2K050726Silverseal Silveraid with X-StaticNoble Fiber Technologies, Inc.20052—
+2K033587SilversealNoble Fiber Technologies20049—
+2K032463Curad Silver BandageBeiersdorf AG20042—
+2K032462Curad Silver Active Gel BandageBeiersdorf AG20040—
+3K150256Silverlon Burn Contact DressingsArgentum Medical20154—
+3K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical20145—
+3K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC20140—
+3K141573Silverlon Island Wound DressingArgentum Medical20140—
+3K140483Asap Otc Wound Dressing GelAbl Medical, LLC20141—
+3K131176Ross RU Skin DiscontinuitiesBiotd S.A.20141—
+3K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs20092—
+3K082910CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC20090—
+3K072378Prowick Antimicrobial Postoperative Wound Dressing, Shoulder and Knee, Models AR-1625…Arthrex, Inc.20071—
+3K063190Silverseal Wound Packing Strips with X-StaticNoble Fiber Technologies, Inc.20070—
+3K050649Silverseal Contacting Wound Dressing with X-StaticNoble Fiber Technologies, Inc.20055—
+4K212521Field Shield Wound DressingKericure, Inc.20240—
+4K190343Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, LLC20193—
+4K180570Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon…Argentum Medical, LLC20191—
+4K180533Procellera Composite Antibacterial Wound DressingVomaris Wound Care, Inc.20180—
+4K180643MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs)Medcu Technologies, Ltd.20181—
+4K162017Ross Ru Wound Dressing GelBiotd S.A.20170—
+4K150985Medihoney Wound GelDerma Sciences, Inc.201501
+4K083133Silveri: Coflex Afd, Coflex Afd First Aid, Afd Pad Foam Dressing, Powerflex Afd Foam…Andover Healthcare, Inc.20093—
+4K083007ProwickArthrex, Inc.20090—
+5K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+5K231088Copper Foam Dressing (Prescription and OTC)Roosin Medical Co., Ltd.20240—
+5K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+5K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+5K221218Silverlon Wound Contact, Burn Contact DressingsArgentum Medical, Inc.20221—
+6K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—
+6K241225Silverlon® Wound Contact, Burn Contact DressingArgentum Medical, LLC20240—