510(k) Report

510(k) · Cleared

Cleared

Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit

K121883510(k) TraditionalCleared Oct 11, 2012105-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 Oct 11, 2012 as substantially equivalent to K100821 (Kci USA, Inc., 2010) after a 105-day review. Its family tree reaches back 1 generation to 2010. 14 later devices descend from it.

Decided
Oct 11, 2012
Review
105 days
Class
Class II
Product code
OMP
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K100821 (2010). 14 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2019: 2 descendants cleared2018: 2 descendants cleared2023: 1 descendant cleared2021: 1 descendant cleared2020: 1 descendant cleared2022: 1 descendant clearedK100821 · Prevena Incision Management System · Kci USA, Inc. · 2010 · recalled2010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 4 descendants5 generations forward: 4 descendants K100821 · Prevena Incision Management System · Kci USA, Inc. · 2010 · recalled0+5
  1. Root · 1 generation backK100821 Prevena Incision Management SystemKci USA, Inc. · 2010 · Recalled
  2. This deviceK121883 Prevena Incision Management System with Customizable Dressing…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2012
  3. Descendant · cites it directly · 12 of its ownK123878 Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.) · 2013 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
  5. Descendant · 3 generations on · 9 of its ownK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
  6. Descendant · 3 generations on · 8 of its ownK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
  7. Descendant · 4 generations on · 7 of its ownK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 22016: 22018: 22019: 22020: 12021: 12022: 12023: 1
2013high 2 (2015) · low 0 (2017)2026

Most influential descendants

Showing 5 of 14 · See all
  • K123878Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.) · 2013 · cites it directly12descendants
  • K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015 · 2 generations on10descendants
  • K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc. · 2016 · 3 generations on9descendants
  • K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsKci USA, Inc. (Kinetic Concepts, Inc.) · 2016 · 3 generations on8descendants
  • K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc. · 2018 · 4 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K100821Prevena Incision Management SystemKci USA, Inc.20108
0 (this device)K121883Prevena Incision Management System with Customizable Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.)2012—
+1K123878Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.)20138
+2K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision…Kci USA, Inc. (Kinetic Concepts, Inc.)2015—
+3K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing…Kci USA, Inc.2016—
+3K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE…Kci USA, Inc. (Kinetic Concepts, Inc.)2016—
+4K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management…Kci USA, Inc.2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201520
201620
201820
201920
202010
202110
202210
202310
FIG. 1 — Lineage of K121883, 2010–2023Source: 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
*K100821Prevena Incision Management System
Summary page 1
…l General and Plastic Surgery Regulation 878.4780 Product Code(s) OMP Legally marketed Prevena Incision Management System (K100821) device(s) to which equivalence Is claimed [21 CFR BO7,92(a)(3)J _________________________________ Device description…
Kci USA, Inc.20108

Also cleared against K100821: 5 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K123878Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.)201312
K150006Prevena Incision Management System with Peel & Place Dressing, Prevena Incision…Kci USA, Inc.20150

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?

  • Its one ancestor has a recall.
  • Of its descendants, K123878 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2013) has gone furthest, with 12 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. 2012, 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 as stated in the FDA summary.

Also cleared against K100821

5 other devices cite the same predicate.

  • 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
  • K133137Cisnap Closed Incision SystemSpiracur, Inc. · 2014
  • 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
  • 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

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
  • K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026

https://510kreport.com/device/K121883 · printed Nov 6, 2026

Cite this page

510(k) Report. “K121883: Prevena Incision Management System with Customizable Dressing, Prevena Customizable Dressing Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121883

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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