510(k) Report

Devices descending from K113199

10 later devices reach Kevo NPWT-AHEMO30 and a HEMO45 Foam Dressing Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151261Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit…Medela AG20159—
+2K170088Invia Foam Dressing Kits with FitPad, Invia Foam Dressing Kits with FitPad, Invia Gauze…Medela AG201781
+3K182409Applied Tissue Technologies PWD™ Platform Wound DressingApplied Tissue Technologies, LLC20192—
+3K180415Invia White Foam NPWTMedela AG20180—
+3K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+4K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+4K223388Invia® Integrated DressingMedela AG20230—
+4K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+4K191460PWD Platform Wound Dressing 3” x 5” OblongApplied Tissue Technologies, LLC20191—
+5K212359PWD Negative Pressure Wound Therapy SystemApplied Tissue Technologies, LLC20220—