510(k) · Cleared
ClearedPrevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci USA, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Nov 6, 2015 as substantially equivalent to K121883 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2012) after a 308-day review. Its family tree reaches back 2 generations to 2010.
- Decided
- Nov 6, 2015
- Review
- 308 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K100821 (2010). No later device cites it as a predicate yet.
- Root · 2 generations backK100821 Prevena Incision Management SystemKci USA, Inc. · 2010 · Recalled
- 1 generation backK121883 Prevena Incision Management System with Customizable Dressing…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2012
- This deviceK150006 Prevena Incision Management System with Peel & Place Dressing…Kci USA, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K100821 | Prevena Incision Management System | Kci USA, Inc. | 2010 | 8 |
| −1 | K121883 | Prevena Incision Management System with Customizable Dressing, Prevena… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012 | — |
| 0 (this device) | K150006 | Prevena Incision Management System with Peel & Place Dressing, Prevena… | Kci USA, Inc. | 2015 | — |
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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121883 | Prevena Incision Management System with Customizable Dressing, Prevena Customizable…Summary page 4…ral and Plastic Surgery Regulation 878.4780 Product Code(s) OMP Legally marketed Prevena™ Incision Management System, cleared under 510(k) K121883 device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)] Device description Negative pressure wou… | 2012 |
| † | K100821 | Prevena Incision Management System | 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 5 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K121883.
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. 2015, 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/K150006 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150006: Prevena Incision Management System with Peel & Place 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 6, 2026. https://510kreport.com/device/K150006
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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