510(k) · Cleared
Recalled · Class II · 2025Prevena Plus 125 Therapy Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M · QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Cleared on Feb 13, 2023 as substantially equivalent to DEN180013 (Kci USA, Inc., 2019) and 1 other predicate after a 112-day review. Its family tree reaches back 9 generations to 1995. It has been recalled once.
- Decided
- Feb 13, 2023
- Review
- 112 days
- Class
- Class II
- Product code
- QFC
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 9 generations to K945062 (1995). 15 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK223263 Prevena Plus 125 Therapy Unit3M · 2023
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 deviceK223263 Prevena Plus 125 Therapy Unit3M · 2023
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) | K223263 | Prevena Plus 125 Therapy Unit | 3M | 2023 | — |
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 |
| 2019 | 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 QFC? 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 QFC device
- #1 K203716 PICO Single Use Negative Pressure Wound…score 2.5 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy UnitsSummary page 4…Class: Class II Product Code Primary: QFC, OMP Dated: October 12, 2022 Received: October 24, 2022 3. Predicate Device Predicate Device: Prevena™ Plus 125 Therapy Unit (DEN180013) Predicate Device: Prevena™ Plus 125 Therapy Unit (K180855) Reference Device: V.A.C. VIA NPWT System (K173447) 4. Device Descrip… | 2019 |
| * | K180855 | Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemSummary page 4…12, 2022 Received: October 24, 2022 3. Predicate Device Predicate Device: Prevena™ Plus 125 Therapy Unit (DEN180013) Predicate Device: Prevena™ Plus 125 Therapy Unit (K180855) Reference Device: V.A.C. VIA NPWT System (K173447) 4. Device Description The Prevena™ Plus 125 Therapy Unit may be used part o… | 2018 |
| † | K173447 | V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 17, 2025 | Class II | Z-1175-2025 | Device Design | Due to increase in complaints related to leak alarms |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate DEN180013.
How does its category compare?
All QFC devicesQFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · QFC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QFC
Too few QFC 510(k)s in any year since 2007 to give a median.
Recalls per year · QFC
No recall names QFC since 2007.
Adverse event reports per year · QFC
1in 2024
MAUDE reports naming product code QFC, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings. The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to…
Read the full statement (197 words)
Prevena Plus 125 Therapy Unit is indicated for use with both the Prevena™ Dressings and compatible V.A.C.® Dressings.
The Prevena Plus 125 Therapy Unit when used with the Prevena™ Dressings (Prevena Plus Incision Management System), manages the environment of closed surgical incisions and removes fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed Prevena Dressings for up to seven days, Prevena Plus 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.
The Prevena ™ Plus 125 Therapy Unit, when used with compatible V.A.C.® Dressings on open wounds (Prevena Plus Negative Pressure Wound Therapy System), is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223263 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223263: Prevena Plus 125 Therapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223263
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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