510(k) · Cleared
Recalled · Class II · 2024V.A.C.ULTA Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kci USA, Inc. (Kinetic Concepts, Inc.) · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jan 26, 2017 as substantially equivalent to K100657 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2010) after a 114-day review. Its family tree reaches back 4 generations to 1995. 3 later devices descend from it. It has been recalled once.
- Decided
- Jan 26, 2017
- Review
- 114 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K945062 (1995). 6 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 3 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 2 generations backK021501 V.a.C. Instillamat (Vacuum Assisted Closure InstillamatKinetic Concepts, Inc. · 2002
- 1 generation backK100657 V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
- This deviceK162790 V.A.C.ULTA Negative Pressure Wound Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2017
- Descendant · cites it directly · 1 of its ownK203316 V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group · 2021
- Descendant · 2 generations on · 0 of its ownK261338 RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK233614 Genadyne DUO NPWTGenadyne Biotechnologies, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemKci, A Part of 3M Health Care Business Group · 2021 · cites it directly1descendant
- K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd. · 2026 · 2 generations on0descendants
- K233614Genadyne DUO NPWTGenadyne Biotechnologies, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −3 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −2 | K021501 | V.a.C. Instillamat (Vacuum Assisted Closure Instillamat | Kinetic Concepts, Inc. | 2002 | — |
| −1 | K100657 | V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
| 0 (this device) | K162790 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2017 | — |
| +1 | K203316 | V.A.C.ULTA Negative Pressure Wound Therapy System | Kci, A Part of 3M Health Care Business Group | 2021 | — |
| +2 | K261338 | RENASYS DYNAFLOW Kit (66807741) | Smith & Nephew Medical, Ltd. | 2026 | — |
| +1 | K233614 | Genadyne DUO NPWT | Genadyne Biotechnologies, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K100657 | V.a.C. Ulta Negative Pressure Wound Therapy System (V.a.C. Ulta Therapy System) Model…Summary page 4…gally marketed device(s) to which equivalence is claimed [21 CFR 807.92(a)(3)] V.A.C.ULTA™ Negative Pressure Wound Therapy System (K100657) Device description [21 CFR 807.92(a)(4)] The V.A.C.ULTA™ Negative Pressure Wound Therapy System… | 2010 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 5, 2024 | Class II | Z-0507-2025 | Use error | Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K203316 (Kci, A Part of 3M Health Care Business Group, 2021) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K100657.
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. 2017, 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.ULTA™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option. • Negative Pressure Wound Therapy in the absence of instillation 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…
Read the full statement (251 words)
The V.A.C.ULTA™ Negative Pressure Wound Therapy System is an integrated wound management system that provides
Negative Pressure Wound Therapy with an instillation option.
• Negative Pressure Wound Therapy in the absence of instillation 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.
• Instillation Therapy 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.ULTA™ Negative Pressure Wound Therapy System with and without instillation is indicated for patients with
chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and
venous insufficiency), flaps and grafts.
• Negative Pressure Wound Therapy in the absence of instillation may also be used for:
o The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal
entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal
compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the
ICU. The abdominal dressing will most often be applied in the operating theater.
o The management of 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/K162790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162790: V.A.C.ULTA Negative Pressure Wound Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162790
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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