510(k) · Cleared
ClearedV.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress
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 Nov 19, 2013 as substantially equivalent to K120033 (Kci USA, Inc., 2012) after a 26-day review. Its family tree reaches back 2 generations to 2010. 9 later devices descend from it.
- Decided
- Nov 19, 2013
- Review
- 26 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K100821 (2010). 9 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK100821 Prevena Incision Management SystemKci USA, Inc. · 2010 · Recalled
- 1 generation backK120033 Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit…Kci USA, Inc. · 2012
- This deviceK133276 V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round…Kci USA, Inc. · 2013
- Descendant · cites it directly · 5 of its ownK181505 V.A.C. DERMATAC DrapeKci USA, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK200390 V.A.C. DERMATAC DrapeKci USA, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK213853 RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam…Smith and Nephew Medical Limited · 2023
- Descendant · 2 generations on · 1 of its ownK212320 Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring…3M Healthcare Business Group · 2021
- Descendant · cites it directly · 0 of its ownK250586 Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits…Deroyal Industries, Inc. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K181505V.A.C. DERMATAC DrapeKci USA, Inc. · 2019 · cites it directly5descendants
- K200390V.A.C. DERMATAC DrapeKci USA, Inc. · 2020 · 2 generations on2descendants
- K213853RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing LargeSmith and Nephew Medical Limited · 2023 · cites it directly1descendant
- K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small…3M Healthcare Business Group · 2021 · 2 generations on1descendant
- K250586Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam…Deroyal Industries, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K100821 | Prevena Incision Management System | Kci USA, Inc. | 2010 | 8 |
| −1 | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac… | Kci USA, Inc. | 2012 | — |
| 0 (this device) | K133276 | V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing… | Kci USA, Inc. | 2013 | — |
| +1 | K181505 | V.A.C. DERMATAC Drape | Kci USA, Inc. | 2019 | — |
| +2 | K200390 | V.A.C. DERMATAC Drape | Kci USA, Inc. | 2020 | — |
| +1 | K213853 | RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT… | Smith and Nephew Medical Limited | 2023 | — |
| +2 | K212320 | Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C.… | 3M Healthcare Business Group | 2021 | — |
| +1 | K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White… | Deroyal Industries, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K120033 | Activac Therapy Unit and Infovac Therapy Unit, Vac Ats Therapy Unit and Vac Freedom…Summary page 1…nder multiple 510(k)s for device(s) to which the KCl V.A.C. Therapy Negative Pressure Wound Therapy Systems. The equivalence Is claimed most recent 51 0(k) was K120033. [21 CFR 807.92(a)(3)J Device description V.A.C. Therapy Wound Dressings for use with KOI's V.AC. NPWT System.F [21 CFR… | 2012 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181505 | V.A.C. DERMATAC Drape | 2019 | 5 |
| K213853 | RENASYS™-WF White Foam NPWT Dressing Small; RENASYS™-WF White Foam NPWT Dressing Large | 2023 | 1 |
| K250586 | Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam… | 2025 | 0 |
| K230233 | Prospera Spectruum Negative Pressure Wound Therapy System | 2024 | 0 |
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 3 years and passes through 1 company; a new generation was cleared every 2.0 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K181505 (Kci USA, Inc., 2019) has gone furthest, with 5 descendants of its own.
- 5 other devices also cite its predicate K120033.
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. 2013, 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., InfoVAC., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings. When used on open wounds, 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…
Read the full statement (142 words)
The ActiV.A.C., InfoVAC., V.A.C. ATS, V.A.C. Freedom, V.A.C. Via, and V.A.C. Simplicity Negative Pressure Wound Therapy Systems are integrated wound management systems for use in acute, extended and home care settings.
When used on open wounds, 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. 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, they are also 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/K133276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133276: V.a.C. Granufoam Dressing, Granufoam Thin Dressing, Granufoam Round Dressing, Granufoam Silver Dressing, Whitefoam Dress.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133276
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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