510(k) · Cleared
ClearedModification to: V.a.C. Granufoam Silver Protection Dressing
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 Feb 6, 2006 as substantially equivalent to K050261 (Kinetic Concepts, Inc., 2005) after a 39-day review. Its family tree reaches back 5 generations to 1991. 5 later devices descend from it.
- Decided
- Feb 6, 2006
- Review
- 39 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914575 (1991). 13 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 4 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 3 generations backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- 2 generations backK024298 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2003
- 1 generation backK050261 V.a.C. Granufoam Silver Protection DressingKinetic Concepts, Inc. · 2005
- This deviceK053627 Modification to: V.a.C. Granufoam Silver Protection DressingKci USA, Inc. · 2006
- Descendant · cites it directly · 3 of its ownK062227 V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2006 · Recalled
- Descendant · 2 generations on · 1 of its ownK083357 Open Abdomen Negative Pressure Therapy System, Model 370502…Kci USA, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK121817 Vcare aIVT Medical, Ltd. · 2013
- Descendant · 3 generations on · 0 of its ownK120499 Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012
- Descendant · cites it directly · 0 of its ownK102956 V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010
Most influential descendants
Showing 5 of 5 · See all- K062227V.a.C. Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2006 · cites it directly3descendants
- K083357Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model 370510Kci USA, Inc. · 2009 · 2 generations on1descendant
- K121817Vcare aIVT Medical, Ltd. · 2013 · 2 generations on0descendants
- K120499Abthera Open Abdomen Negative Pressure Therapy SystemKci USA, Inc. (Kinetic Concepts, Inc.) · 2012 · 3 generations on0descendants
- K102956V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium Dressing; V.a.C.…Kci USA, Inc. (Kinetic Concepts, Inc.) · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −4 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −3 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| −2 | K024298 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2003 | — |
| −1 | K050261 | V.a.C. Granufoam Silver Protection Dressing | Kinetic Concepts, Inc. | 2005 | — |
| 0 (this device) | K053627 | Modification to: V.a.C. Granufoam Silver Protection Dressing | Kci USA, Inc. | 2006 | — |
| +1 | K062227 | V.a.C. Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2006 | 2 |
| +2 | K083357 | Open Abdomen Negative Pressure Therapy System, Model 370502, Canister, Model… | Kci USA, Inc. | 2009 | — |
| +2 | K121817 | Vcare a | IVT Medical, Ltd. | 2013 | — |
| +3 | K120499 | Abthera Open Abdomen Negative Pressure Therapy System | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2012 | — |
| +1 | K102956 | V.a.C. Granufoam Silver Small Dressing; V.a.C. Granufoam Silver Medium… | Kci USA, Inc. (Kinetic Concepts, Inc.) | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K050261 | V.a.C. Granufoam Silver Protection Dressing Our reading of the summary gave K050260, FDA’s number for Bioresorb Macro Pore (Oraltronics Dental Implant Technology GmbH). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “V.A.C.® GranuFoam® Silver Protection dressing”. | 2005 |
What descends from it? (5)
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 15 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K062227 (Kci USA, Inc. (Kinetic Concepts, Inc.), 2006) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K050261.
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 Protection dressing is intended for use with the V.A.C. ® family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute, and dehisced wounds, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053627 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053627: Modification to: V.a.C. Granufoam Silver Protection Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053627
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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