510(k) · Cleared
ClearedPrevena Incision Management System with Customizable Dressing, Prevena Incision Managemant System with Peel& Place Dres
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Mar 24, 2014 as substantially equivalent to K123878 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2013) and 1 other predicate after a 154-day review. Its family tree reaches back 3 generations to 2010.
- Decided
- Mar 24, 2014
- Review
- 154 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K100821 (2010). No later device cites it as a predicate yet.
- Root · 3 generations backK100821 Prevena Incision Management SystemKci USA, Inc. · 2010 · Recalled
- 2 generations backK121883 Prevena Incision Management System with Customizable Dressing…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2012
- 1 generation backK123878 Prevena Incision Management System with Customizable DressingKci USA, Inc. (Kinetic Concepts, Inc.) · 2013 · Recalled
- This deviceK133232 Prevena Incision Management System with Customizable Dressing…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K100821 | Prevena Incision Management System | Kci USA, Inc. | 2010 | 8 |
| −2 | K121883 | Prevena Incision Management System with Customizable Dressing, Prevena… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012 | — |
| −1 | K123878 | Prevena Incision Management System with Customizable Dressing | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2013 | 8 |
| 0 (this device) | K133232 | Prevena Incision Management System with Customizable Dressing, Prevena… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2014 | — |
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 K260646 Renasys Edge (66803126)score 15.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K123878 | Prevena Incision Management System with Customizable DressingSummary page 1…lastic Surgery Regulation 878.4780 Product Code(s) OMP Legally marketed Prevena Incision Management System with Customnizable Dressing (K123878) device(s) to which Prevena Incision Management System with Peel & Place Dressing (K100821) equivalence is claimed [21 CIF… | 2013 |
| * | K100821 | Prevena Incision Management SystemSummary page 1…Prevena Incision Management System with Customnizable Dressing (K123878) device(s) to which Prevena Incision Management System with Peel & Place Dressing (K100821) equivalence is claimed [21 CIFR 807.92(a)(3)] __________________________________ Device description Negative pressure w… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 4 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 1 other device also cites its predicate K123878.
How does its category compare?
All OMP devicesOMP Negative Pressure Wound Therapy Powered Suction Pump: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OMP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OMP
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OMP
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OMP
140in 2025
MAUDE reports naming product code OMP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 113 | 0 | 1 |
| 2008 | 8 | 98 | 0 | 1 |
| 2009 | 8 | 87 | 7 | 79 |
| 2010 | 6 | 97 | 3 | 80 |
| 2011 | 6 | 123 | 0 | 130 |
| 2012 | 11 | 292 | 1 | 97 |
| 2013 | 11 | 84 | 2 | 169 |
| 2014 | 10 | 179 | 4 | 229 |
| 2015 | 20 | 189 | 1 | 378 |
| 2016 | 19 | 146 | 2 | 398 |
| 2017 | 11 | 137 | 0 | 368 |
| 2018 | 13 | 214 | 0 | 422 |
| 2019 | 15 | 249 | 1 | 994 |
| 2020 | 6 | 179 | 0 | 3,664 |
| 2021 | 9 | 238 | 0 | 1,422 |
| 2022 | 10 | 229 | 0 | 258 |
| 2023 | 8 | 291 | 0 | 143 |
| 2024 | 9 | 181 | 2 | 135 |
| 2025 | 5 | 127 | 0 | 140 |
| 2026 | 9 | 141 | 0 | — |
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.
https://510kreport.com/device/K133232 · printed Nov 3, 2026
Cite this page
510(k) Report. “K133232: Prevena Incision Management System with Customizable Dressing, Prevena Incision Managemant System with Peel& Place Dres.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133232
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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