510(k) · Cleared
Recalled · Class II · 2014Prevena Incision Management System
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 Jun 11, 2010 after an 80-day review. The FDA summary names its predicate without a number. 67 later devices descend from it. It has been recalled 8 times.
- Decided
- Jun 11, 2010
- Review
- 80 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 8
- Predicates
- 0
67 later devices descend from it, 6 citing it directly.
- This deviceK100821 Prevena Incision Management SystemKci USA, Inc. · 2010
- Descendant · cites it directly · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
- Descendant · cites it directly · 25 of its ownK120033 Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit…Kci USA, Inc. · 2012
- Descendant · 2 generations on · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- Descendant · 3 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- Descendant · cites it directly · 14 of its ownK121883 Prevena Incision Management System with Customizable Dressing…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2012
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K111170PICOSmith & Nephew, Inc. · 2011 · cites it directly26descendants
- K120033Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom…Kci USA, Inc. · 2012 · cites it directly25descendants
- K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · 2 generations on25descendants
- K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 3 generations on23descendants
- K121883Prevena Incision Management System with Customizable Dressing, Prevena Customizable…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2012 · cites it directly14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K100821 | Prevena Incision Management System | Kci USA, Inc. | 2010 | — |
| +1 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| +1 | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac… | Kci USA, Inc. | 2012 | — |
| +2 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| +3 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| +1 | K121883 | Prevena Incision Management System with Customizable Dressing, Prevena… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 7 | 0 |
| 2020 | 6 | 0 |
| 2021 | 4 | 0 |
| 2022 | 6 | 0 |
| 2023 | 6 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 0 |
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 |
|---|---|---|---|
| * | — | ActiV.A.C. Therapy System Named without a submission number |
What descends from it? (67)
See all 676 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111170 | PICO | 2011 | 26 |
| K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom… | 2012 | 25 |
| K121883 | Prevena Incision Management System with Customizable Dressing, Prevena Customizable… | 2012 | 14 |
| K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision Management… | 2015 | 10 |
| K133232 | Prevena Incision Management System with Customizable Dressing, Prevena Incision… | 2014 | 0 |
| K133137 | Cisnap Closed Incision System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 30, 2014 | Class II | Z-1141-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
| Jan 30, 2014 | Class II | Z-1135-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
| Jan 30, 2014 | Class II | Z-1137-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
| Jan 30, 2014 | Class II | Z-1138-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
| Jan 30, 2014 | Class II | Z-1136-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
| Jan 30, 2014 | Class II | Z-1142-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
| Jan 30, 2014 | Class II | Z-1139-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
| Jan 30, 2014 | Class II | Z-1140-2014 | Nonconforming Material/Component | Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111170 (Smith & Nephew, Inc., 2011) has gone furthest, with 26 descendants of its own.
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. 2010, 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/K100821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100821: Prevena Incision Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100821
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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