510(k) · Cleared
ClearedSilverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG Antimicrobial Wound Contact Negativ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Argentum Medical, LLC · OMP Negative Pressure Wound Therapy Powered Suction Pump
Cleared on Sep 12, 2014 as substantially equivalent to K050261 (Kinetic Concepts, Inc., 2005) and 4 other predicates after a 143-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Sep 12, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- OMP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K914575 (1991). 32 ancestors in all, the oldest K890354 (1989). No later device cites it as a predicate yet.
- 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 deviceK141033 Silverlon Antimicrobial Wound Contact Negative Pressure Dressings…Argentum Medical, LLC · 2014
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) | 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 |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 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? (5)
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 DressingSummary page 5…Silverlon® Fenestrated Wound Contact Dressings 5.6. Classification name Powered suction pump (accessory) 5.7. Substantially Equivalent Devices (Predicates): K050261; V.A.C. GranuFoam Silver Protection Dressing K041642; V.A.C. GranuFoamTM Silver Dressing K080275; Kalypto Medical’s NPD 1000 (Wou… | 2005 |
| * | K041642 | V.a.C. Granufoam Silver DressingSummary page 5…6. Classification name Powered suction pump (accessory) 5.7. Substantially Equivalent Devices (Predicates): K050261; V.A.C. GranuFoam Silver Protection Dressing K041642; V.A.C. GranuFoamTM Silver Dressing K080275; Kalypto Medical’s NPD 1000 (Wound Dressing Set ) K981299; Silverlon Contact Wound Dr… | 2005 |
| * | K080275 | NPD 1000 Negative Pressure Wound Therapy SystemSummary page 5…ump (accessory) 5.7. Substantially Equivalent Devices (Predicates): K050261; V.A.C. GranuFoam Silver Protection Dressing K041642; V.A.C. GranuFoamTM Silver Dressing K080275; Kalypto Medical’s NPD 1000 (Wound Dressing Set ) K981299; Silverlon Contact Wound Dressing (1 and 4 Layer) K122817; SILVERLON IS… | 2008 |
| * | K981299 | Silverlon Contact Wound DressingSummary page 5…(Predicates): K050261; V.A.C. GranuFoam Silver Protection Dressing K041642; V.A.C. GranuFoamTM Silver Dressing K080275; Kalypto Medical’s NPD 1000 (Wound Dressing Set ) K981299; Silverlon Contact Wound Dressing (1 and 4 Layer) K122817; SILVERLON ISLAND WOUND DRESSING 5.8. Description of Device Silve… | 1998 |
| * | K122817 | Silverlon Island Wound Dressing Cleared while this submission was under review Summary page 5…Dressing K041642; V.A.C. GranuFoamTM Silver Dressing K080275; Kalypto Medical’s NPD 1000 (Wound Dressing Set ) K981299; Silverlon Contact Wound Dressing (1 and 4 Layer) K122817; SILVERLON ISLAND WOUND DRESSING 5.8. Description of Device Silverlon® Fenestrated Wound Contact Dressings—Models Silverlon… | 2014 |
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 23 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- 3 of the 32 ancestors have a recall of any class.
- 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. 2014, 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?
Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic}, partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for…
Read the full statement (146 words)
Silverlon® Antimicrobial Wound Contact Negative Pressure Dressing and the Silverlon® Easy Ag™ Antimicrobial Wound Contact Negative Pressure Dressing are intended to provide moist wound environment and are used for the management of chronic, acute, surgical, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic}, partial-thickness burns, flaps and grafts; when used in conjunction with an NPWT pump that is intended to be used for negative pressure wound therapy (NPWT), the NPWT system is indicated for patients who benefit from wound management therapy via the application of negative pressure wound therapy for removal of fluids and excess exudates, infectious material, and tissue debris which may promote wound healing. It provides a non-adherent, conformable, antimicrobial barrier and may help reduce infection when placed under reticulated foam, gauze, or other wound fillers. Silverlon® Fenestrated Wound Contact Dressings may be cut or overlapped to fit any wound size.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K141033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141033: Silverlon Antimicrobial Wound Contact Negative Pressure Dressings, Silverlon Easy AG Antimicrobial Wound Contact Negativ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141033
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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