510(k) Report

510(k) · Cleared

Cleared

Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing,

K141017510(k) TraditionalCleared Aug 20, 2015486-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. (Kinetic Concepts, Inc.) · OMP Negative Pressure Wound Therapy Powered Suction Pump

Cleared on Aug 20, 2015 as substantially equivalent to K100821 (Kci USA, Inc., 2010) and 2 other predicates after a 486-day review. Its family tree reaches back 4 generations to 1995. 10 later devices descend from it.

Decided
Aug 20, 2015
Review
486 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K945062 (1995). 9 ancestors in all. 10 later devices descend from it, 2 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 ancestor2016: 2 descendants cleared2019: 2 descendants cleared2018: 2 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant clearedK945062 · 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.) · 20101995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 4 descendants 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 · 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. · 19950
  1. Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
  2. 3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
  3. 2 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
  4. 1 generation backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
  5. This deviceK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
  6. Descendant · cites it directly · 9 of its ownK153199 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 · 2 generations on · 7 of its ownK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018
  9. Descendant · 2 generations on · 5 of its ownK180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision…Kci USA, Inc. · 2018
  10. Descendant · 2 generations on · 1 of its ownK181507 PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2016: 22018: 22019: 22020: 12021: 12022: 12023: 1
2016high 2 (2016) · low 0 (2017)2026

Most influential descendants

Showing 5 of 10 · See all
  • K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc. · 2016 · cites it directly9descendants
  • 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 · 2 generations on7descendants
  • K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc. · 2018 · 2 generations on5descendants
  • K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

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

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
201620
201820
201920
202010
202110
202210
202310
FIG. 1 — Lineage of K141017, 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? (3)

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
*K100821Prevena Incision Management System
Summary page 4
…n 878.4780 Regulatory Class II Product Code(s) OMP Legally marketed Prevena Incision Management System with Peel & Place Dressing (K100821) device(s) to which Prevena Incision Management System with Customizable Dressing (K123878) equivalence is claimed V.A.C.…
Kci USA, Inc.20108
*K123878Prevena Incision Management System with Customizable Dressing
Summary page 4
…d Prevena Incision Management System with Peel & Place Dressing (K100821) device(s) to which Prevena Incision Management System with Customizable Dressing (K123878) equivalence is claimed V.A.C.Ulta Negative Pressure Wound Therapy System (K100657) [21 CFR 807.92(a)(3)] Device description…
Kci USA, Inc. (Kinetic Concepts, Inc.)20138
*K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…
Summary page 4
…ice(s) to which Prevena Incision Management System with Customizable Dressing (K123878) equivalence is claimed V.A.C.Ulta Negative Pressure Wound Therapy System (K100657) [21 CFR 807.92(a)(3)] Device description The Prevena Incision Management System provides surgical incision [21 CFR 807.92(…
Kci USA, Inc. (Kinetic Concepts, Inc.)2010—

Also cleared against K100821: 5 other devices →

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc.20169
K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.)20168

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 20 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
  • 2 of the 9 ancestors have a recall of any class.
  • Of its descendants, K153199 (Kci USA, Inc., 2016) has gone furthest, with 9 descendants of its own.
  • 5 other devices also cite its predicate K100821.

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. 2015, 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 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 K100821

5 other devices cite the same predicate.

  • K133232Prevena Incision Management System with Customizable Dressing, Prevena Incision Managemant System with Peel&…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2014
  • K133137Cisnap Closed Incision SystemSpiracur, Inc. · 2014
  • K121883Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing KitKci USA, Inc. (Kinetic Concepts, Inc.) · 2012
  • K120033Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom Therapy Unit, Vac Via…Kci USA, Inc. · 2012
  • K111170PICOSmith & Nephew, Inc. · 2011

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

13 FDA decisions under this applicant name. See the company

  • 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
  • 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

Recent decisions in OMP

The OMP category page

  • K261982RENASYS ABDO SHIELD Temporary Abdominal Closure Kit (66807747)Smith & Nephew Medical, Ltd. · 2026
  • K260426MeCare Alpha (MCA2019)IVT Medical, Ltd. · 2026
  • K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
  • K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc Building · 2026
  • K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026

https://510kreport.com/device/K141017 · printed Nov 3, 2026

Cite this page

510(k) Report. “K141017: Prevena Incision Management System with Peel & Dressing, Prevena Incision Management System with Customizable Dressing,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K141017

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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