510(k) · Cleared
ClearedPREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag)
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 22, 2019 as substantially equivalent to K173426 (Kci USA, Inc., 2018) and 1 other predicate after a 249-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Nov 22, 2019
- Review
- 249 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K945062 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 7 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 6 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
- 5 generations backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
- 4 generations backK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
- 3 generations backK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
- 2 generations backK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
- 1 generation backK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018
- This deviceK190697 PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO…Kci USA, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −7 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −6 | K021501 | V.a.C. Instillamat (Vacuum Assisted Closure Instillamat | Kinetic Concepts, Inc. | 2002 | — |
| −5 | K100657 | V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
| −4 | K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2015 | — |
| −3 | K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing… | Kci USA, Inc. | 2016 | — |
| −2 | 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 | — |
| 0 (this device) | K190697 | PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision… | Kci USA, Inc. | 2019 | — |
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 |
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 |
|---|---|---|---|
| * | K173426 | PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemSummary page 5…urgery panel Regulation 878.4780 Product Code(s) OMP Legally marketed device(s) to which equivalence is • PREVENA PLUS Incision Management System (K173426) claimed • PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (K161… | 2018 |
| * | K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsSummary page 5…ENA PLUS Incision Management System (K173426) claimed • PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings (K161897) [21 CFR 807.92(a)(3)] Device • PREVENA PLUS Incision Management System with PREVENA PEEL description… | 2016 |
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 24 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K173426.
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. 2019, 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 PLUS Incision Management System (No Ag) 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 (No Ag) 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190697 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190697: PREVENA PLUS Incision Management System (No Ag); PREVENA PLUS DUO Incision Management System (No Ag).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190697
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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