510(k) Report

Devices descending from K120033

25 later devices reach Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203369Avance Solo Negative Pressure Wound Therapy (NPWT) SystemMolnlycke Health Care Us, LLC20210—
+1K183543ACTIV.A.C. Therapy UnitKci USA, Inc.201941
+1K172145Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy…Medela AG20183—
+1K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemKci USA, Inc.20160—
+1K133276V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam…Kci USA, Inc.20139—
+1K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc.20134—
+2K254019Wound Geni NPWT SystemBechtel Medical, Inc.20260—
+2K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…Deroyal Industries, Inc.20250—
+2K241515NEXA™ NPWT SystemNexa Medical Limited20240—
+2K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc.20240—
+2K223388Invia® Integrated DressingMedela AG20230—
+2K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing LargeSmith and Nephew Medical Limited20231—
+2K214112Invia Ease Negative Pressure Wound Therapy (NPWT) SystemMedela AG20220—
+2K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc.20203—
+2K181505V.A.C. DERMATAC DrapeKci USA, Inc.20195—
+2K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative…Kci USA, Inc.20180—
+2K162610NEXA Negative Pressure Wound Therapy SystemNexa Medical, Ltd.20170—
+2K161432MyNeWT Negative Pressure Wound Therapy SystemStortford Medical, LLC20170—
+3K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd.20260—
+3K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc.20240—
+3K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small…3M Healthcare Business Group20211—
+3K200390V.A.C. DERMATAC DrapeKci USA, Inc.20202—
+4K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete…3M Healthcare Business Group20230—
+4K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place…3M20230—
+4K220560Dermatac Drape3M20220—