510(k) · Cleared
Recalled · 2009V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000
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 Jun 7, 2007 as substantially equivalent to K032310 (Kinetic Concepts, Inc., 2003) after a 176-day review. Its family tree reaches back 3 generations to 1995. 60 later devices descend from it. It has been recalled once.
- Decided
- Jun 7, 2007
- Review
- 176 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K945062 (1995). 4 ancestors in all. 60 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 1 generation backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- This deviceK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007
- Descendant · cites it directly · 37 of its ownK080275 NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008
- Descendant · 2 generations on · 26 of its ownK111170 PICOSmith & Nephew, Inc. · 2011
- Descendant · 2 generations on · 25 of its ownK112127 Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012
- Descendant · 3 generations on · 23 of its ownK151436 PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016
- Descendant · cites it directly · 17 of its ownK093526 V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
Showing 5 of 60 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 60 · See all- K080275NPD 1000 Negative Pressure Wound Therapy SystemIasis Medical, Inc. · 2008 · cites it directly37descendants
- K111170PICOSmith & Nephew, Inc. · 2011 · 2 generations on26descendants
- K112127Pico Single Use Negative Pressure Wound Therapy SystemSmith & Nephew, Inc. · 2012 · 2 generations on25descendants
- K151436PICO Single Use Negative Pressure Wound Therapy SystemSmith & Nephew Medical, Ltd. · 2016 · 3 generations on23descendants
- K093526V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C. Via…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −1 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| 0 (this device) | K063692 | V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 | Kci USA, Inc. | 2007 | — |
| +1 | K080275 | NPD 1000 Negative Pressure Wound Therapy System | Iasis Medical, Inc. | 2008 | — |
| +2 | K111170 | PICO | Smith & Nephew, Inc. | 2011 | — |
| +2 | K112127 | Pico Single Use Negative Pressure Wound Therapy System | Smith & Nephew, Inc. | 2012 | — |
| +3 | K151436 | PICO Single Use Negative Pressure Wound Therapy System | Smith & Nephew Medical, Ltd. | 2016 | — |
| +1 | K093526 | V.a.C. Via Therapy System, V.a.C. Via Negative Pressure Therapy Unit, V.a.C.… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 7 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. AtsSummary page 1…V.AC. Freedom' Therapy Unit, Legally marketed which was cleared for market entry in the V.A.C.® Family of device to which Products 510(k) K032310. It was also included in the V.A.C.® equivalence is Therapy System 510(k) K062227 which provided text relating c… | 2003 |
| † | K062227 | V.a.C. Therapy System | 2006 |
What descends from it? (60)
See all 604 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2009 | Not classified | Z-0665-2010 | Nonconforming Material/Component | Power cords may crack and fail inside plug with potential for fire hazard. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K080275 (Iasis Medical, Inc., 2008) has gone furthest, with 37 descendants of its own.
- 13 other devices also cite its predicate K032310.
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. 2007, 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 V.A.C.® Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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. It is indicated for patients with chronic, acute…
Read the full statement (105 words)
The V.A.C.® Therapy System is an integrated wound management system for use in acute, extended and home care settings. It 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
The V.A.C.® GranuFoam® Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063692 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063692: V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063692
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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