510(k) · Cleared
ClearedV.a.C. Granufoam Silver Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinetic Concepts, Inc. · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Jan 25, 2005 as substantially equivalent to K032310 (Kinetic Concepts, Inc., 2003) and 1 other predicate after a 222-day review. Its family tree reaches back 3 generations to 1995. 8 later devices descend from it.
- Decided
- Jan 25, 2005
- Review
- 222 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K945062 (1995). 5 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK945062 VacplusKinetic Concepts, Inc. · 1995
- 2 generations backK971548 AmbuvacKinetic Concepts, Inc. · 1997
- 1 generation backK032310 Mini V.a.C., V.a.C. Freedom, V.a.C. AtsKinetic Concepts, Inc. · 2003 · Recalled
- This deviceK041642 V.a.C. Granufoam Silver DressingKinetic Concepts, Inc. · 2005
- Descendant · cites it directly · 7 of its ownK050261 V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK053627 Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc. · 2006
- Descendant · 3 generations on · 3 of its ownK062227 V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2006 · Recalled
- Descendant · 4 generations on · 1 of its ownK083357 Open Abdomen Negative Pressure Therapy System, Model 370502…Kci USA, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK141033 Silverlon Antimicrobial Wound Contact Negative Pressure Dressings…Argentum Medical, LLC · 2014
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K050261V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005 · cites it directly7descendants
- K053627Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc. · 2006 · 2 generations on5descendants
- K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2006 · 3 generations on3descendants
- K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc. · 2009 · 4 generations on1descendant
- K141033Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG…Argentum Medical, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K945062 | Vacplus | Kinetic Concepts, Inc. | 1995 | — |
| −2 | K971548 | Ambuvac | Kinetic Concepts, Inc. | 1997 | — |
| −1 | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. Ats | Kinetic Concepts, Inc. | 2003 | 2 |
| 0 (this device) | K041642 | V.a.C. Granufoam Silver Dressing | Kinetic Concepts, Inc. | 2005 | — |
| +1 | K050261 | V.a.C. Granufoam Silver Protection Dressing | Kinetic Concepts, Inc. | 2005 | — |
| +2 | K053627 | Modification to: V.a.C. Granufoam Silver Protection Dressing | Kci USA, Inc. | 2006 | — |
| +3 | K062227 | V.a.C. Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2006 | 2 |
| +4 | K083357 | Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model… | Kci USA, Inc. | 2009 | — |
| +1 | K141033 | Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon… | Argentum Medical, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 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 |
|---|---|---|---|
| * | K032310 | Mini V.a.C., V.a.C. Freedom, V.a.C. AtsSummary page 1…21 CFR 878.4780 Class II 6. Predicate Devices: V.A.C.® GranuFoam Tm dressing (K032310) Acticoat 7 Day Antimicrobial Dressing (K001519) 7. Description of Device… | 2003 |
| * | K001519 | Acticoat 7 DressingSummary page 1…ss II 6. Predicate Devices: V.A.C.® GranuFoam Tm dressing (K032310) Acticoat 7 Day Antimicrobial Dressing (K001519) 7. Description of Device The V.A.C.® GranuFoamTM Silver dressing is a modification to the V.A.C. product l… | 2000 |
What descends from it? (8)
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)
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 10 years and passes through 1 company; a new generation was cleared every 2.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K050261 (Kinetic Concepts, Inc., 2005) has gone furthest, with 7 descendants of its own.
- 13 other devices also cite its predicate K032310.
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.
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. GranuFoam Silver Dressing is indicated as an effective barrier to bacterial penetration for patients who would benefit from the V.A.C. family of negative pressure devices to help promote wound healing. The barrier functions of the dressing may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts, and partial burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041642 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041642: V.a.C. Granufoam Silver Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041642
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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