510(k) · Cleared
ClearedVac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100
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 Dec 29, 2009 after a 210-day review. The FDA summary names its predicate without a number. 39 later devices descend from it.
- Decided
- Dec 29, 2009
- Review
- 210 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 0
39 later devices descend from it, 3 citing it directly.
- This deviceK091585 Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and…Kci USA, Inc. · 2009
- Descendant · cites it directly · 19 of its ownK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
- 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
- Descendant · 2 generations on · 11 of its ownK113678 Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012
- Descendant · 2 generations on · 10 of its ownK141017 Prevena Incision Management System with Peel & Dressing, Prevena…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015
- Descendant · 3 generations on · 9 of its ownK153199 Prevena Plus Incision Management System Kit with Peel & Place…Kci USA, Inc. · 2016
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K100657V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010 · cites it directly19descendants
- 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
- K113678Invia Motion Negative Pressure Wound Therapy SystemMedela AG · 2012 · 2 generations on11descendants
- K141017Prevena Incision Management System with Peel & Dressing, Prevena Incision Management…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2015 · 2 generations on10descendants
- K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus…Kci USA, Inc. · 2016 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K091585 | Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100 | Kci USA, Inc. | 2009 | — |
| +1 | K100657 | V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
| +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 | — |
| +2 | K113678 | Invia Motion Negative Pressure Wound Therapy System | Medela AG | 2012 | — |
| +2 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | V.A.C. Therapy System Family of Products Named without a submission number |
What descends from it? (39)
See all 393 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, K100657 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2010) has gone furthest, with 19 descendants of its own.
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. 2009, 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 ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. They are 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. They…
Read the full statement (169 words)
The ActiV.A.C.®, InfoV.A.C.®, V.A.C. ATS®, and V.A.C. Freedom® Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. They are 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. They are indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), 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.
The V.A.C.® Instill device is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed. The V.A.C.® Instill is intended for patients with 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/K091585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091585: Vac Therapy System, Models 340000, M8259999, 320000, M8259968 and 320100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091585
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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