510(k) · Cleared
Recalled · Class II · 2020ACTIV.A.C. Therapy Unit
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 Mar 20, 2019 as substantially equivalent to K063692 (Kci USA, Inc., 2007) and 1 other predicate after a 90-day review. Its family tree reaches back 4 generations to 1995. 4 later devices descend from it. It has been recalled once.
- Decided
- Mar 20, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- OMP
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K945062 (1995). 7 ancestors in all. 4 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 backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 1 generation backK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
- This deviceK183543 ACTIV.A.C. Therapy UnitKci USA, Inc. · 2019
- Descendant · cites it directly · 3 of its ownK201571 ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK253199 Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK241134 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK230233 Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc. · 2024
Most influential descendants
Showing 4 of 4 · See all- K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. · 2020 · cites it directly3descendants
- K253199Curasys 2 (EMDN0003)CG Bio Co., Ltd. · 2026 · 2 generations on0descendants
- K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)Kci USA, Inc. · 2024 · 2 generations on0descendants
- K230233Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, 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 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −1 | K063692 | V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 | Kci USA, Inc. | 2007 | 1 |
| 0 (this device) | K183543 | ACTIV.A.C. Therapy Unit | Kci USA, Inc. | 2019 | — |
| +1 | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | Kci USA, Inc. | 2020 | — |
| +2 | K253199 | Curasys 2 (EMDN0003) | CG Bio Co., Ltd. | 2026 | — |
| +2 | K241134 | 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) | Kci USA, Inc. | 2024 | — |
| +1 | K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | Deroyal Industries, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K063692 | V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Summary page 4…ponents) 510(k) Number: K18543 Regulatory Number: 21 CFR 878.4780 Regulatory Class: II Product Code: OMP Predicate Device KCI USA, Inc., ACTIV.A.C.™ Therapy Unit (K063692, K120033) Device Description The ACTIV.A.C.™ Therapy Unit is a component of the ACTIV.A.C.™ Negative Pressure Wound Therapy (NP… | 2007 |
| * | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom…Summary page 4…510(k) Number: K18543 Regulatory Number: 21 CFR 878.4780 Regulatory Class: II Product Code: OMP Predicate Device KCI USA, Inc., ACTIV.A.C.™ Therapy Unit (K063692, K120033) Device Description The ACTIV.A.C.™ Therapy Unit is a component of the ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) Syste… | 2012 |
What descends from it? (4)
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 |
|---|---|---|---|---|
| Jun 8, 2020 | Class II | Z-2542-2020 | Under Investigation by firm | The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 2 companies; a new generation was cleared every 6.4 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K201571 (Kci USA, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K063692.
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. 2019, 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.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings. When used on open wounds, 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. Open…
Read the full statement (132 words)
The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.
When used on open wounds, 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. 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.
When used on closed surgical incisions, it is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183543 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183543: ACTIV.A.C. Therapy Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K183543
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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