510(k) · Cleared
ClearedAllevyn AG Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · FRO Dressing, Wound, Drug
Cleared on Aug 3, 2007 as substantially equivalent to K050030 (Smith & Nephew, Inc., 2005) and 1 other predicate after a 220-day review. Its family tree reaches back 2 generations to 2000. 3 later devices descend from it.
- Decided
- Aug 3, 2007
- Review
- 220 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K000051 (2000). 3 ancestors in all, the oldest K963096 (1996). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK000051 Acticoat Foam DressingWestaim Biomedical, Inc. · 2000 · Recalled
- 1 generation backK050030 Acticoat Moisture Control DressingSmith & Nephew, Inc. · 2005
- This deviceK063835 Allevyn AG DressingSmith & Nephew, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK110062 Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AGMedipurpose Pte., Ltd. · 2011
- Descendant · 2 generations on · 0 of its ownK141619 Luofucon Silver Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK091013 Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited · 2009
Most influential descendants
Showing 3 of 3 · See all- K110062Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AGMedipurpose Pte., Ltd. · 2011 · cites it directly1descendant
- K141619Luofucon Silver Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 2 generations on0descendants
- K091013Silver PU Antibacterial Foam Dressing - Non Adherent and IslandAdvanced Medical Solutions Limited · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000051 | Acticoat Foam Dressing | Westaim Biomedical, Inc. | 2000 | 1 |
| −1 | K050030 | Acticoat Moisture Control Dressing | Smith & Nephew, Inc. | 2005 | — |
| 0 (this device) | K063835 | Allevyn AG Dressing | Smith & Nephew, Inc. | 2007 | — |
| +1 | K110062 | Mediplus-Foam AG; Mediplus-Comfortfoam AG; Mediplus-Superfoam AG | Medipurpose Pte., Ltd. | 2011 | — |
| +2 | K141619 | Luofucon Silver Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
| +1 | K091013 | Silver PU Antibacterial Foam Dressing - Non Adherent and Island | Advanced Medical Solutions Limited | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K050030 | Acticoat Moisture Control DressingSummary page 2…At this time however, Classification Code FRO is unclassified. 6. Predicate devices Allevyn Ag is similar in form and function to Acticoat Moisture Control Dressing (K050030) while being a modification of the Allevyn Foam Dressing (K963096) via the incorporation of Silver Sulfadiazine (SSD) within the… | 2005 |
| * | K963096 | Allevyn Hydro Poly Dressing ND All Trac DressingSummary page 2…6. Predicate devices Allevyn Ag is similar in form and function to Acticoat Moisture Control Dressing (K050030) while being a modification of the Allevyn Foam Dressing (K963096) via the incorporation of Silver Sulfadiazine (SSD) within the absorbent foam core. Allevyn Ag has all the features and benefits… | 1996 |
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 7 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K110062 (Medipurpose Pte., Ltd., 2011) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K050030.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
The Allevyn Ag Dressings are indicated for use in light to moderately exuding partial and full thickness wounds including decubitus ulcers, diabetic ulcers, It and 2nd degree bums, and donor sites. Allevyn Ag may be used over debrided and partial thickness wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063835 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063835: Allevyn AG Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063835
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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