510(k) Report

Devices descending from K990530

21 later devices reach Kerlix MD Antimicrobial Gauze Dressing through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142962PROTOCOL Incision DressingDeroyal Industries20150—
+1K070653Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Tyco Healthcare20077—
+1K053476AllwoundAt Squared, LLC20061—
+1K024054Xylos Xcell Antimicrobial DressingXylos Corporation20037—
+1K011941Excilon Amd Antimicrobial Sponge Model #7088The Kendall Company20011—
+2K211943Microlyte Ag/LidocaineImbed Biosciences20240—
+2K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…Winner Medical Co., Ltd.20230—
+2K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc.20125—
+2K093351Collawound ArtCollamatrix, Inc.20100—
+2K070685Kendall Antimicrobial Drain Dressing for Otc Use, Model 6662Tyco Healthcare20070—
+2K050032Euromed Sureskin Iii with Silver Wound DressingsEuromed, Inc.20062—
+2K051647Fortaderm Antimicrobial Wound DressingOrganogenesis, Inc.20053—
+3K251582Redermax Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20261—
+3K221532PHMB Wound DressingWinner Medical Co., Ltd.20230—
+3K151186Stay Fresh Hydrocolloid dressingSarasota Medical Products, Inc.20150—
+3K130857Prontosan Wound Gel XB.Braun Medical, Inc.20133—
+3K081274Sureskin Silver BandagesEuromed, Inc.20081—
+4K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.20260—
+4K223259coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20231—
+4K192527Rochal Antimicrobial Wound GelRochal Industries, LLC20202—
+5K241809coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.20240—