510(k) Report

FDA applicant

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

San Antonio, TX13 decisions2006–201711 recalls

FDA records 13 decisions for Kci USA, Inc. (Kinetic Concepts, Inc.) (San Antonio, TX) from 2006 to 2017: 13 510(k) clearances. All are in product code OMP (Negative Pressure Wound Therapy Powered…). Since 2016 its 510(k)s took a median of 114 days from receipt to decision, against 146 for FDA’s reviews in the same codes and years. Its devices cite 23 predicates, 8 of them its own earlier devices. 11 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Kci USA, Inc. (Kinetic Concepts, Inc.)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2010: 32011: 12012: 22013: 12014: 12015: 12016: 22017: 1
2007high 3 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2025

2009: 12014: 82024: 12025: 1
2007high 8 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Kci USA, Inc. (Kinetic Concepts, Inc.) by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Kci USA, Inc. (Kinetic Concepts, Inc.)’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump13decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 114 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 146 days; 3 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 23 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 21 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.) · 20164cite it
  • K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.a.C. Ulta Therapy…Kci USA, Inc. (Kinetic Concepts, Inc.) · 20103cite it
  • K093526V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via Dressing (Containing V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.) · 20102cite it
  • K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 20172cite it
  • K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with…Kci USA, Inc. (Kinetic Concepts, Inc.) · 20152cite it
  • K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 20062cite it

What has FDA decided for it lately?

  • K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 20171 recall
  • K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.) · 2016
  • K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
  • K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
  • K133232Prevena Incision Management System with Customizable Dressing, Prevena Incision Managemant System with Peel&…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2014
  • K123878Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.) · 20138 recalls
  • K121883Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing KitKci USA, Inc. (Kinetic Concepts, Inc.) · 2012
  • K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012

All 13 as Kci USA, Inc. (Kinetic Concepts, Inc.) →

What has been recalled?

11 recalls linked to its devices; the latest:

  • K0622273M V.A.C. VIA Negative Pressure Wound Therapy System REF: VIAKIT077D01/US - V.A.C. VIA 7…Jan 17, 2025Class II
  • K162790V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative…Nov 5, 2024Class II
  • K100821PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage…Jan 30, 2014Class II
  • K100821PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision…Jan 30, 2014Class II
  • K100821PRE1055: Prevena Dressing, 5 Pack Product Usage: The Prevena Incision Management System…Jan 30, 2014Class II
  • K100821PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision…Jan 30, 2014Class II