510(k) · Cleared
ClearedPREVENA RESTOR (TM) 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 Feb 15, 2019 as substantially equivalent to K180855 (Kci USA, Inc., 2018) and 2 other predicates after a 253-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it.
- Decided
- Feb 15, 2019
- Review
- 253 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K945062 (1995). 14 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations between
- 3 generations backK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
- 2 generations backK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018
- 1 generation backK180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision…Kci USA, Inc. · 2018
- This deviceK181507 PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK220660 Prevena Restor Adapti-Form Dressing3M Healthcare Business Group · 2022
Show all 9 generations
- Root · 9 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 8 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 7 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
- 6 generations backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
- 5 generations backK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
- 4 generations backK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
- 3 generations backK161897 PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2016
- 2 generations backK173426 PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision…Kci USA, Inc. · 2018
- 1 generation backK180855 Prevena Plus Incision Management System, Prevena Plus Duo Incision…Kci USA, Inc. · 2018
- This deviceK181507 PREVENA RESTOR (TM) Incision Management SystemKci USA, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K220660Prevena Restor Adapti-Form Dressing3M Healthcare Business Group · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −8 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −7 | K021501 | V.a.C. Instillamat (Vacuum Assisted Closure Instillamat | Kinetic Concepts, Inc. | 2002 | — |
| −6 | K100657 | V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
| −5 | K141017 | Prevena Incision Management System with Peel & Dressing, Prevena Incision… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2015 | — |
| −4 | K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing… | Kci USA, Inc. | 2016 | — |
| −3 | K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2016 | — |
| −2 | 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 | — |
| 0 (this device) | K181507 | PREVENA RESTOR (TM) Incision Management System | Kci USA, Inc. | 2019 | — |
| +1 | 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 |
|---|---|---|
| 2022 | 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? (3)
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 |
|---|---|---|---|
| * | K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemSummary page 4…egulation 21 CFR 878.4780 Regulatory Class II Product Code(s) OMP Legally marketed Predicate 510(k) Number(s): device(s) to which K180855 equivalence is K161897 claimed K153199 [21 CFR 807.92(a)(3)] Device description The negati… | 2018 |
| * | K161897 | PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsSummary page 4…8.4780 Regulatory Class II Product Code(s) OMP Legally marketed Predicate 510(k) Number(s): device(s) to which K180855 equivalence is K161897 claimed K153199 [21 CFR 807.92(a)(3)] Device description The negative pressure technology for the s… | 2016 |
| * | K153199 | Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Summary page 4…t Code(s) OMP Legally marketed Predicate 510(k) Number(s): device(s) to which K180855 equivalence is K161897 claimed K153199 [21 CFR 807.92(a)(3)] Device description The negative pressure technology for the subject device is the same as [21 CFR 807… | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220660 | Prevena Restor Adapti-Form Dressing | 2022 | 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 24 years and passes through 3 companies; a new generation was cleared every 1.4 years on median.
- 2 of the 14 ancestors have a recall of any class.
- Of its descendants, K220660 (3M Healthcare Business Group, 2022) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K180855.
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 RESTOR(TM) 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/K181507 · printed Nov 5, 2026
Cite this page
510(k) Report. “K181507: PREVENA RESTOR (TM) Incision Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K181507
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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