510(k) · Cleared
ClearedAfm Ultra AG Dressings
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Milliken & Co. · FRO Dressing, Wound, Drug
Cleared on Feb 17, 2010 as substantially equivalent to K051445 (Milliken Chemical, 2005) and 1 other predicate after a 131-day review. Its family tree reaches back 5 generations to 1992. 1 later device descends from it.
- Decided
- Feb 17, 2010
- Review
- 131 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914579 (1992). 14 ancestors in all, the oldest K871166 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK023612 Silverlon Contact Wound DressingArgentum International, LLC · 2003
- 1 generation backK051445 Milliken Silver Wound DressingsMilliken Chemical · 2005
- This deviceK093188 Afm Ultra AG DressingsMilliken & Co. · 2010
- Descendant · cites it directly · 0 of its ownK141603 Ultra Silver DressingsMilliken Healthcare Products, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- K141603Ultra Silver DressingsMilliken Healthcare Products, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K023612 | Silverlon Contact Wound Dressing | Argentum International, LLC | 2003 | — |
| −1 | K051445 | Milliken Silver Wound Dressings | Milliken Chemical | 2005 | — |
| 0 (this device) | K093188 | Afm Ultra AG Dressings | Milliken & Co. | 2010 | — |
| +1 | K141603 | Ultra Silver Dressings | Milliken Healthcare Products, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K051445 | Milliken Silver Wound DressingsSummary page 2…icrobial testing demonstrates that AEM Ultra Ag Dressings are substantially equivalent in design, function and intended use to Milliken Silver Wound Dressings (K051445) and Contreet Foam Adhesive/ Nonadhesive (K0224 16). Milliken & Company February 16, 2010 Additiona… | 2005 |
| * | K022416 | Contreet Foam Adhesive/Non-AdhesiveSummary page 1…lassification Name: Dressing, Wound, Drug 3. PREDICATE DEVICES * Milliken Silver Wound Dressing (KO5 1445) * Contreet Foam Adhesive/Nonadhesive (K0224 16) 4. DEVICEc DESCRIPTION The AFM Ultra Ag Dressings are sterile, single-use wound care dressings for use in moist wound… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141603 | Ultra Silver Dressings | 2014 | 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 18 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K141603 (Milliken Healthcare Products, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K051445.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
AEM Ultra Ag 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/K093188 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093188: Afm Ultra AG Dressings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093188
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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