510(k) · Cleared
ClearedProspera Spectruum Negative Pressure Wound Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Apr 18, 2024 as substantially equivalent to K183543 (Kci USA, Inc., 2019) and 2 other predicates after a 447-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Apr 18, 2024
- Review
- 447 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K945062 (1995). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 5 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 4 generations backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- 3 generations backK063692 V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000Kci USA, Inc. · 2007 · Recalled
- 2 generations backK183543 ACTIV.A.C. Therapy UnitKci USA, Inc. · 2019 · Recalled
- 1 generation backK201571 ACTIV.A.C. Negative Pressure Wound Therapy SystemKci USA, Inc. · 2020
- This deviceK230233 Prospera Spectruum Negative Pressure Wound Therapy SystemDeroyal Industries, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −5 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −4 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| −3 | K063692 | V.a.C. Therapy Systems-Acti V.a.C. Therapy Unit Model# 340000 | Kci USA, Inc. | 2007 | 1 |
| −2 | K183543 | ACTIV.A.C. Therapy Unit | Kci USA, Inc. | 2019 | 1 |
| −1 | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy System | Kci USA, Inc. | 2020 | — |
| 0 (this device) | 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 |
| 2013 | 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? (3)
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 |
|---|---|---|---|
| * | K183543 | ACTIV.A.C. Therapy UnitSummary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K183543 ACTIV.A.C. Therapy Unit OMP K201571… | 2019 |
| * | K201571 | ACTIV.A.C. Negative Pressure Wound Therapy SystemSummary page 5…Product Code K183543 ACTIV.A.C. Therapy Unit OMP K201571 ACTIV.A.C.™ Negative Pressure Wound Therapy System OMP K133276… | 2020 |
| * | K133276 | V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam…Summary page 5…OMP K201571 ACTIV.A.C.™ Negative Pressure Wound Therapy System OMP K133276 V.A.C. Therapy Wound Dressings OMP Device Des… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- 4 of the 10 ancestors have a recall of any class.
- 1 other device also cites its predicate K183543.
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. 2024, 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 Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended 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.…
Read the full statement (164 words)
The Prospera Spectruum™ Negative Pressure Wound Therapy System is a wound management system intended 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.
The Prospera Spectruum™ Negative Pressure Wound Therapy System is only intended to be used with the Granufoam wound interface dressing and V.A.C. Drape components from the V.A.C. Therapy Wound Dressing kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230233 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230233: Prospera Spectruum 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/K230233
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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