510(k) · Cleared
ClearedPREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
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 Oct 4, 2016 as substantially equivalent to K141017 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2015) and 1 other predicate after an 85-day review. Its family tree reaches back 6 generations to 1995. 8 later devices descend from it.
- Decided
- Oct 4, 2016
- Review
- 85 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K945062 (1995). 11 ancestors in all. 8 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 4 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
- 3 generations backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
- 2 generations backK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
- 1 generation backK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
- This deviceK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
- Descendant · cites it directly · 7 of its ownK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018
- Descendant · cites it directly · 5 of its ownK180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision…Kci USA, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK181507 PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK223263 Prevena Plus 125 Therapy Unit3M · 2023 · Recalled
- Descendant · 2 generations on · 0 of its ownK220660 Prevena Restor Adapti-Form Dressing3M Healthcare Business Group · 2022
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemKci USA, Inc. · 2018 · cites it directly7descendants
- K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemKci USA, Inc. · 2018 · cites it directly5descendants
- K181507PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019 · cites it directly1descendant
- K223263Prevena Plus 125 Therapy Unit3M · 2023 · 2 generations on0descendants
- K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −4 | K021501 | V.a.C. Instillamat (Vacuum Assisted Closure Instillamat | Kinetic Concepts, Inc. | 2002 | — |
| −3 | K100657 | V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
| −2 | K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2015 | — |
| −1 | K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing… | Kci USA, Inc. | 2016 | — |
| 0 (this device) | K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016 | — |
| +1 | K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management… | Kci USA, Inc. | 2018 | — |
| +1 | K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management… | Kci USA, Inc. | 2018 | — |
| +1 | K181507 | PREVENA RESTOR (TM) Incision Management System | Kci USA, Inc. | 2019 | — |
| +2 | K223263 | Prevena Plus 125 Therapy Unit | 3M | 2023 | 1 |
| +2 | K220660 | Prevena Restor Adapti-Form Dressing | 3M Healthcare Business Group | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 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? (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 |
|---|---|---|---|
| * | K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Summary page 4…878.4780 Product Code(s) OMP Legally marketed • PREVENA Incision Management System, cleared recently under device(s) to which 510(k) K141017 equivalence is claimed • PREVENA PLUS Incision Management System, cleared recently [21 CFR 807.92(a)(3)] under 510(k… | 2015 |
| * | K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Summary page 4…(s) to which 510(k) K141017 equivalence is claimed • PREVENA PLUS Incision Management System, cleared recently [21 CFR 807.92(a)(3)] under 510(k) K153199 Device description Both the PREVENA DUOTM Incision Management System (with the [21 CFR 807.92(a)(4)] PREVENA 125 Therapy… | 2016 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System | 2018 | 7 |
| K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System | 2018 | 5 |
| K181507 | PREVENA RESTOR (TM) Incision Management System | 2019 | 1 |
| K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management… | 2019 | 0 |
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 21 years and passes through 3 companies; a new generation was cleared every 4.9 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K173426 (Kci USA, Inc., 2018) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K141017.
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. 2016, 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 DUO 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.
The PREVENA PLUS DUO 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/K161897 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161897: PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161897
Report an extraction error
Are you the manufacturer?
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