510(k) Report

FDA applicant

Kci USA, Inc.

San Antonio, TX28 decisions2006–202414 recalls

FDA records 28 decisions for Kci USA, Inc. (San Antonio, TX) from 2006 to 2024: 27 510(k) clearances and 1 De Novo grant. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and QFC (Negative Pressure Wound Therapy Device For…). Since 2016 its 510(k)s took a median of 118 days from receipt to decision, against 214 for FDA’s reviews in the same codes and years. Its devices cite 35 predicates, 19 of them its own earlier devices. 14 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.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007: 32009: 32010: 12011: 12012: 12013: 32015: 12016: 22018: 32019: 52020: 22024: 1
2007high 5 (2019) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2020

2008: 22009: 22014: 82017: 12020: 1
2007high 8 (2014) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Kci USA, 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 Pump26decisions
  • QFCNegative Pressure Wound Therapy Device For Reduction Of Wound Complications1decision
  • FTLMesh, Surgical, Polymeric1decision

How long do its 510(k) reviews take?

Since 2016, its 12 510(k)s took a median of 118 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 214 days; 8 of its 12 were faster than that.

Whose devices does it build on?

Its devices cite 35 predicates; 19 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 58 times; 19 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.

  • K120033Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via…Kci USA, Inc. · 20126cite it
  • K100821Prevena Incision Management SystemKci USA, Inc. · 20106cite it
  • K133276V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing…Kci USA, Inc. · 20134cite it
  • K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc. · 20134cite it
  • K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing…Kci USA, Inc. · 20164cite it
  • K063692V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 20074cite it

What has FDA decided for it lately?

  • K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc. · 2024
  • K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. · 2020
  • K200390V.A.C. DERMATAC DrapeKci USA, Inc. · 2020
  • K190697PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)Kci USA, Inc. · 2019
  • DEN180013PREVENA 125 and PREVENA PLUS 125 Therapy UnitsKci USA, Inc. · 2019
  • K181505V.A.C. DERMATAC DrapeKci USA, Inc. · 2019
  • K183543ACTIV.A.C. Therapy UnitKci USA, Inc. · 20191 recall
  • K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019

All 28 as Kci USA, Inc. →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K183543ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI…Jun 8, 2020Class II
  • K0637401000 ml Canister (with Gel) for InfoV.A.C. and V.A.C.ULTA Therapy Systems (Part Number…Apr 28, 2017Class 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