De Novo · Granted
GrantedPREVENA 125 and PREVENA PLUS 125 Therapy Units
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci USA, Inc. · QFC Negative Pressure Wound Therapy Device For Reduction Of Wound Complications
Granted on Apr 19, 2019 as a new device type through De Novo after a 400-day review. 2 later devices descend from it.
- Decided
- Apr 19, 2019
- Review
- 400 days
- Class
- Class II
- Product code
- QFC
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceDEN180013 PREVENA 125 and PREVENA PLUS 125 Therapy UnitsKci USA, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK223263 Prevena Plus 125 Therapy Unit3M · 2023 · Recalled
- Descendant · cites it directly · 0 of its ownK203716 PICO Single Use Negative Pressure Wound Therapy System, PICO 7…Smith and Nephew Medical Limited · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN180013 | PREVENA 125 and PREVENA PLUS 125 Therapy Units | Kci USA, Inc. | 2019 | — |
| +1 | K223263 | Prevena Plus 125 Therapy Unit | 3M | 2023 | 1 |
| +1 | K203716 | PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use… | Smith and Nephew Medical Limited | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA De Novo 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 K223263 Prevena Plus 125 Therapy Unitscore 5.2 · 9 generations · no Class I recall
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K223263 (3M, 2023) has gone furthest, with 0 descendants of its own.
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. 2019, 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 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN180013 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN180013: PREVENA 125 and PREVENA PLUS 125 Therapy Units.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN180013
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