510(k) Report

Devices descending from K100218

11 later devices reach Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K254246LT Antibacterial Foam with Silver DressingZhejiang Longterm Medical Technology Co., Ltd.20260—
+1K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd.20201—
+1K191536Biatain Silicone AgColoplast A/S20200—
+1K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20155—
+1K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S20122—
+2K223359LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20230—
+2K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd.20230—
+2K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd.20163—
+3K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd.20172—
+4K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd.20241—
+5K242856LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd.20240—