510(k) Report

510(k) · Cleared

Cleared

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

K153199510(k) TraditionalCleared Feb 29, 2016119-day reviewClass II21 CFR 878.4780

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Kci USA, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Feb 29, 2016 as substantially equivalent to K141017 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2015) after a 119-day review. Its family tree reaches back 5 generations to 1995. 9 later devices descend from it.

Decided
Feb 29, 2016
Review
119 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K945062 (1995). 10 ancestors in all. 9 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2010: 1 other ancestor2012: 1 other ancestor2009: 1 other ancestor2000: 1 other ancestor2019: 2 descendants cleared2016: 1 descendant cleared2018: 2 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant clearedReference device: K132741 · V.a.C. Via Negative Pressure Wound Therapy System · Kci USA, Inc. · 2013K945062 · Vacplus · Kinetic Concepts, Inc. · 1995K971548 · Ambuvac · Kinetic Concepts, Inc. · 1997K021501 · V.a.C. Instillamat (Vacuum Assisted Closure Instillamat · Kinetic Concepts, Inc. · 2002K100657 · V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.a.C. Ulta Therapy Unit Model U · Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010K141017 · Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing, · Kci USA, Inc. (Kinetic Concepts, Inc.) · 20151995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 5 descendants K141017 · Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing, · Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015K100657 · V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model V.a.C. Ulta Therapy Unit Model U · Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010K021501 · V.a.C. Instillamat (Vacuum Assisted Closure Instillamat · Kinetic Concepts, Inc. · 2002K971548 · Ambuvac · Kinetic Concepts, Inc. · 1997K945062 · Vacplus · Kinetic Concepts, Inc. · 1995−50
  1. Root · 5 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
  2. 4 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
  3. 3 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
  4. 2 generations backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
  5. 1 generation backK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
  6. This deviceK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
  7. Descendant · cites it directly · 8 of its ownK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
  8. Descendant · cites it directly · 7 of its ownK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018
  9. Descendant · cites it directly · 5 of its ownK180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision…Kci USA, Inc. · 2018
  10. Descendant · cites it directly · 1 of its ownK181507 PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019
  11. Descendant · 2 generations on · 0 of its ownK223263 Prevena Plus 125 Therapy Unit3M · 2023 · Recalled

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2016: 12018: 22019: 22020: 12021: 12022: 12023: 1
2016high 2 (2018) · low 0 (2017)2026

Most influential descendants

Showing 5 of 9 · See all
  • K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.) · 2016 · cites it directly8descendants
  • K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc. · 2018 · cites it directly7descendants
  • K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc. · 2018 · cites it directly5descendants
  • K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019 · cites it directly1descendant
  • K223263Prevena Plus 125 Therapy Unit3M · 2023 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K945062VacplusKinetic Concepts, Inc.1995—
−4K971548AmbuvacKinetic Concepts, Inc.1997—
−3K021501V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc.2002—
−2K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy…Kci USA, Inc. (Kinetic Concepts, Inc.)2010—
−1K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision…Kci USA, Inc. (Kinetic Concepts, Inc.)2015—
0 (this device)K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing…Kci USA, Inc.2016—
+1K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE…Kci USA, Inc. (Kinetic Concepts, Inc.)2016—
+1K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management…Kci USA, Inc.2018—
+1K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management…Kci USA, Inc.2018—
+1K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.2019—
+2K223263Prevena Plus 125 Therapy Unit3M20231

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200910
201010
201210
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201820
201920
202010
202110
202210
202310
FIG. 1 — Lineage of K153199, 1995–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OMP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OMP device

  1. #1 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…
Summary page 4
…d | Prevena Incision Management System with Peel & Place and Customizable device(s) to which equlvalence is claime [21 CFR 807. 92(a)(3)] | Dressings (as cleared under K141017) Dewce;ggs»crlptlon [21 CFR 807.92(a)(4)] | The Prevena Plus Incision Management System provides surgical incision - | managem…
Kci USA, Inc. (Kinetic Concepts, Inc.)2015—
†K132741V.a.C. Via Negative Pressure Wound Therapy SystemKci USA, Inc.2013—

Also cleared against K141017: 1 other device →

What descends from it? (9)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)20168
K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc.20187
K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc.20185
K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc.20191

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
  • 2 of the 10 ancestors have a recall of any class.
  • Of its descendants, K161897 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2016) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K141017.

How does its category compare?

All OMP devices

OMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · OMP

5in 2025

2007: 62008: 82009: 82010: 62011: 62012: 112013: 112014: 102015: 202016: 192017: 112018: 132019: 152020: 62021: 92022: 102023: 82024: 92025: 52026 (partial year): 9
2007high 20 (2015) · low 5 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OMP

127in 2025

2007: 113 days median2008: 98 days median2009: 87 days median2010: 97 days median2011: 123 days median2012: 292 days median2013: 84 days median2014: 179 days median2015: 189 days median2016: 146 days median2017: 137 days median2018: 214 days median2019: 249 days median2020: 179 days median2021: 238 days median2022: 229 days median2023: 291 days median2024: 181 days median2025: 127 days median2026 (partial year): 141 days median
2007high 292 (2012) · low 84 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OMP

2in 2024

2009: 72010: 32012: 12013: 22014: 42015: 12016: 22019: 12024: 2
2007high 7 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OMP

140in 2025

2007: 12008: 12009: 792010: 802011: 1302012: 972013: 1692014: 2292015: 3782016: 3982017: 3682018: 4222019: 9942020: 3,6642021: 1,4222022: 2582023: 1432024: 1352025: 140
2007high 3,664 (2020) · low 1 (2007)2025

MAUDE reports naming product code OMP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611301
200889801
2009887779
2010697380
201161230130
201211292197
201311842169
2014101794229
2015201891378
2016191462398
2017111370368
2018132140422
2019152491994
2020617903,664
2021923801,422
2022102290258
202382910143
202491812135
202551270140
202691410—

What is it indicated for?

The Prevena Plus Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment, and removing exudate via the application of negative pressure wound therapy.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K141017

1 other device cites the same predicate.

  • K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.) · 2016

More from Kci USA, Inc.

28 FDA decisions under this applicant name. See the company

  • 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

Recent decisions in OMP

The OMP category page

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  • K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
  • K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026
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https://510kreport.com/device/K153199 · printed Nov 3, 2026

Cite this page

510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K153199

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026