KCI USA, INC.
FDA Regulatory Profile
KCI USA, INC. appears in FDA public data with 19 recalls, 28 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1175-2025, Class II) was initiated on January 17, 2025. Its most recent 510(k) clearance was granted on May 23, 2024.
Summary
- Total Recalls
- 19
- 510(k) Clearances
- 28
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1175-2025 | Class II | 3M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US Prevena Plus Duo Peel and Place 20 | January 17, 2025 |
| Z-1176-2025 | Class II | 3M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7 Day Kit | January 17, 2025 |
| Z-0507-2025 | Class II | V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C.¿ Ulta Negative Pressure Wound | November 5, 2024 |
| Z-2542-2020 | Class II | ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008 | June 8, 2020 |
| Z-2171-2017 | Class II | 1000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number M8275093/5). | April 28, 2017 |
| Z-0600-2016 | Class II | ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. The | November 25, 2015 |
| Z-0933-2015 | Class II | CelluTome Epidermal Harvesting System Harvester (5.0 CM) STERILE EO Rx Only Manufactured for: KCI US | November 19, 2014 |
| Z-0070-2015 | Class II | V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infec | September 18, 2014 |
| Z-2717-2014 | Class II | CelluTome Epidermal Harvesting System Part number CT-H25 or Part Number CT-H50 | May 19, 2014 |
| Z-1136-2014 | Class II | PRE1001US: Prevena Peel and Place System Kit (US-ONLY) Product Usage: The Prevena Incision Mana | January 30, 2014 |
| Z-1140-2014 | Class II | PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management Sys | January 30, 2014 |
| Z-1142-2014 | Class II | PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Ma | January 30, 2014 |
| Z-1139-2014 | Class II | PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision | January 30, 2014 |
| Z-1137-2014 | Class II | PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System is inten | January 30, 2014 |
| Z-1135-2014 | Class II | PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management Syste | January 30, 2014 |
| Z-1138-2014 | Class II | PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management Sys | January 30, 2014 |
| Z-1141-2014 | Class II | PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prev | January 30, 2014 |
| Z-2466-2012 | Class II | BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed | September 17, 2012 |
| Z-0409-2013 | Class II | RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complica | June 27, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241134 | 3M ActiV.A.C. Canister - 300ml with Gel (M8275058/5, M8275058/10) | May 23, 2024 |
| K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | July 8, 2020 |
| K200390 | V.A.C. DERMATAC Drape | May 18, 2020 |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag) | November 22, 2019 |
| DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | April 19, 2019 |
| K181505 | V.A.C. DERMATAC Drape | March 28, 2019 |
| K183543 | ACTIV.A.C. Therapy Unit | March 20, 2019 |
| K181507 | PREVENA RESTOR(TM) Incision Management System | February 15, 2019 |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | June 1, 2018 |
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | March 9, 2018 |
| K173447 | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound | March 2, 2018 |
| K160487 | V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System | December 9, 2016 |
| K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dr | February 29, 2016 |
| K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System wi | November 6, 2015 |
| K133276 | V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESS | November 19, 2013 |
| K132741 | V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEM | November 15, 2013 |
| K123507 | KCI NPWT GAUZE DRESSING | April 4, 2013 |
| K120033 | ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VA | May 31, 2012 |
| K111280 | V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNIT | July 21, 2011 |
| K100821 | PREVENA INCISION MANAGEMENT SYSTEM | June 11, 2010 |