510(k) · Cleared
ClearedMilliken Silver Wound Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milliken Chemical · FRO Dressing, Wound, Drug
Cleared on Aug 22, 2005 as substantially equivalent to K023612 (Argentum International, LLC, 2003) and 1 other predicate after an 81-day review. Its family tree reaches back 4 generations to 1992. 3 later devices descend from it.
- Decided
- Aug 22, 2005
- Review
- 81 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914579 (1992). 7 ancestors in all, the oldest K890354 (1989). 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 1 generation backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- This deviceK051445 Milliken Silver Wound DressingsMilliken Chemical · 2005
- Descendant · cites it directly · 1 of its ownK093188 Afm Ultra AG DressingsMilliken & Co. · 2010
- Descendant · 2 generations on · 0 of its ownK141603 Ultra Silver DressingsMilliken Healthcare Products, LLC · 2014
- Descendant · cites it directly · 0 of its ownK103141 Low Adherent Afm AG DressingsMilliken Healthcare Products, LLC · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −1 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| 0 (this device) | K051445 | Milliken Silver Wound Dressings | Milliken Chemical | 2005 | — |
| +1 | K093188 | Afm Ultra AG Dressings | Milliken & Co. | 2010 | — |
| +2 | K141603 | Ultra Silver Dressings | Milliken Healthcare Products, LLC | 2014 | — |
| +1 | K103141 | Low Adherent Afm AG Dressings | Milliken Healthcare Products, LLC | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 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 FRO? 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 FRO device
- #1 K261023 Microdacyn Wound Irrigation Solutionscore 15.5 · 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 |
|---|---|---|---|
| * | K023612 | Silverlon Contact Wound DressingSummary page 1…l Name: Wound Dressing Classification Name: Dressing 3. PREDICATE DEVICES * Argenturn Medical LLC Silverlon® Wound Contact Dressing (K023612) * Westaim Biomedical ActicoatTM 7 Dressing (K001519) 4. DEVICE DESCRIPTION Milliken's Silver Wound Dressin… | 2003 |
| * | K001519 | Acticoat 7 DressingSummary page 1…Dressing 3. PREDICATE DEVICES * Argenturn Medical LLC Silverlon® Wound Contact Dressing (K023612) * Westaim Biomedical ActicoatTM 7 Dressing (K001519) 4. DEVICE DESCRIPTION Milliken's Silver Wound Dressings are sterile, single-use wound care dressings for use… | 2000 |
What descends from it? (3)
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 13 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K093188 (Milliken & Co., 2010) has gone furthest, with 1 descendant of its own.
- 9 other devices also cite its predicate K023612.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRO
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRO
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRO
2in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FRO
192in 2025
MAUDE reports naming product code FRO, 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 | 29 | 187 | 4 | 55 |
| 2008 | 26 | 130 | 1 | 30 |
| 2009 | 31 | 136 | 1 | 45 |
| 2010 | 31 | 146 | 0 | 122 |
| 2011 | 27 | 177 | 4 | 42 |
| 2012 | 24 | 96 | 0 | 65 |
| 2013 | 19 | 194 | 1 | 139 |
| 2014 | 22 | 214 | 1 | 269 |
| 2015 | 28 | 249 | 2 | 297 |
| 2016 | 28 | 222 | 3 | 147 |
| 2017 | 23 | 147 | 1 | 149 |
| 2018 | 20 | 206 | 0 | 128 |
| 2019 | 16 | 270 | 1 | 136 |
| 2020 | 12 | 226 | 0 | 139 |
| 2021 | 8 | 275 | 6 | 183 |
| 2022 | 9 | 332 | 2 | 176 |
| 2023 | 18 | 283 | 2 (2) | 198 |
| 2024 | 24 | 263 | 2 | 232 |
| 2025 | 11 | 176 | 0 | 192 |
| 2026 | 17 | 254 | 2 | — |
What is it indicated for?
The Milliken Silver Wound Dressings provide an antimicrobial barrier to microbial
colonization in the dressing and reduce microbial penetration through the dressing.
Milliken Silver Wound Dressings are indicated for management of partial thickness
burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV
dermal ulcers (vascular, venous, pressure and diabetic).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051445 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051445: Milliken Silver Wound Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051445
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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