# Kci USA, Inc.

- Location (FDA's records): San Antonio, TX
- FDA decisions: 28 (2006–2024): 27 510(k) clearances and 1 De Novo grant
- Product codes: OMP (26), QFC (1), FTL (1)
- 510(k) review time since 2016: median 118 days, against 214 for FDA's reviews in the same codes and years (8 of 12 faster)
- Predicates its devices cite: 35 (19 its own); citations of its devices by later devices: 58 (19 its own)
- Recalls linked to its devices: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kci USA, Inc. (Kinetic Concepts, Inc.): 8 (https://510kreport.com/company/kci-usa-kinetic-concepts)
- Kinetic Concepts, Inc.: 7 (https://510kreport.com/company/kinetic-concepts)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Firms that cite its devices most
- Kci USA, Inc. (Kinetic Concepts, Inc.): 11 (https://510kreport.com/company/kci-usa-kinetic-concepts)
- Deroyal Industries, Inc.: 4 (https://510kreport.com/company/deroyal-industries)
- 3M Healthcare Business Group: 3 (https://510kreport.com/company/3m-healthcare-business-group)
- 3M Company: 3 (https://510kreport.com/company/3m)
- Integrated Healing Technologies: 2 (https://510kreport.com/company/integrated-healing-technologies)
- Smith and Nephew Medical Limited: 2 (https://510kreport.com/company/smith-and-nephew-medical)
- Spiracur, Inc.: 2 (https://510kreport.com/company/spiracur)
- Cardinalhealth: 2 (https://510kreport.com/company/cardinalhealth)

## Its most-cited devices
- K120033: Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via Therapy Unit (2012), cited by 6
- K100821: Prevena Incision Management System (2010), cited by 6
- K133276: V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress (2013), cited by 4
- K132741: V.a.C. Via Negative Pressure Wound Therapy System (2013), cited by 4
- K153199: Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack (2016), cited by 4
- K063692: V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 (2007), cited by 4

## Recent decisions
- 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 (Jul 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) (Nov 22, 2019)
- DEN180013: PREVENA 125 and PREVENA PLUS 125 Therapy Units (Apr 19, 2019)
- K181505: V.A.C. DERMATAC Drape (Mar 28, 2019)
- K183543: ACTIV.A.C. Therapy Unit (Mar 20, 2019)
- K181507: PREVENA RESTOR (TM) Incision Management System (Feb 15, 2019)

Source page: https://510kreport.com/company/kci-usa