# Kci USA, Inc. (Kinetic Concepts, Inc.)

- Location (FDA's records): San Antonio, TX
- FDA decisions: 13 (2006–2017): 13 510(k) clearances
- Product codes: OMP (13)
- 510(k) review time since 2016: median 114 days, against 146 for FDA's reviews in the same codes and years (3 of 3 faster)
- Predicates its devices cite: 23 (8 its own); citations of its devices by later devices: 21 (8 its own)
- Recalls linked to its devices: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Kci USA, Inc.: 11 (https://510kreport.com/company/kci-usa)
- Kinetic Concepts, Inc.: 4 (https://510kreport.com/company/kinetic-concepts)

## Firms that cite its devices most
- Kci USA, Inc.: 8 (https://510kreport.com/company/kci-usa)
- 3M Healthcare Business Group: 1 (https://510kreport.com/company/3m-healthcare-business-group)
- Medela AG: 1 (https://510kreport.com/company/medela)
- IVT Medical, Ltd.: 1 (https://510kreport.com/company/ivt-medical)
- Kci, A Part of 3M Health Care Business Group: 1 (https://510kreport.com/company/kci-a-part-of-3m-health-care-business-group)
- Genadyne Biotechnologies, Inc.: 1 (https://510kreport.com/company/genadyne-biotechnologies)

## Its most-cited devices
- K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (2016), cited by 4
- K100657: V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.a.C. Ulta Therapy Unit Model U (2010), cited by 3
- K093526: V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via Dressing (Containing V.a.C. Granufoam D (2010), cited by 2
- K162790: V.A.C.ULTA Negative Pressure Wound Therapy System (2017), cited by 2
- K141017: Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing, (2015), cited by 2
- K062227: V.a.C. Therapy System (2006), cited by 2

## Recent decisions
- K162790: V.A.C.ULTA Negative Pressure Wound Therapy System (Jan 26, 2017)
- K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (Oct 4, 2016)
- K160451: V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ... (Jun 20, 2016)
- K141017: Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing, (Aug 20, 2015)
- K133232: Prevena Incision Management System  with Customizable Dressing, Prevena Incision Managemant System with Peel& Place Dres (Mar 24, 2014)
- K123878: Prevena Incision Management System with Customizable Dressing (Jan 15, 2013)
- K121883: Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit (Oct 11, 2012)
- K120499: Abthera Open Abdomen Negative Pressure Therapy System (Oct 5, 2012)

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