510(k) · Cleared
Recalled · Class II · 2022Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non Adhesive
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 6, 2013 as substantially equivalent to K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) and 1 other predicate after a 205-day review. Its family tree reaches back 4 generations to 1992. It has been recalled once.
- Decided
- Jun 6, 2013
- Review
- 205 days
- Class
- Class U
- Product code
- FRO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K914604 (1992). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 3 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 2 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 1 generation backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- This deviceK123481 Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and…Convatec, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −3 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −2 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −1 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| 0 (this device) | K123481 | Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non Adhesive | Convatec, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (3)
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 |
|---|---|---|---|
| * | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingSummary page 2…h Silver, Adhesive and Non-Adhesive is substantially equivalent to ConvaTec’s previously cleared Hydrofiber™ technology based products ( AQUACEL™ Ag Hydrofiber™ Dressing K080383 and AQUACEL™ Foam Hydrofiber™ Foam Dressing, NAC, Exempt)} and MoInlycke Health Care’s Mepilex Border Ag Foam Dressing ( K100029)… | 2008 |
| * | K100029 | Mepilex Border AG DressingSummary page 1…evices: AQUACEL™ Ag Hydrofiber‘;" Dressing, . KO80383, AQUACEL™ Foam Hydrofiber™ Foam Dressing {Adhesive and Non-Adhesive), Exempt, NAC Mepilex Border Ag Foam Dressing, K100029 Device Description AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, Adhesive and Non-Adhesive is a soft, sterile foam wo… | 2010 |
| * | — | AQUACEL™ Foam Hydrofiber™ Foam Dressing (Adhesive and Non-Adhesive), NAC Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 15, 2022 | Class II | Z-0723-2023 | Process control | ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 8 ancestors has a recall.
- 14 other devices also cite its predicate K080383.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Under the supervision of a healthcare professional:
AQUACEL™ Ag Foam Hydrofiber™ Foam Dressing with Silver, adhesive and non adhesive may be used for the management of both chronic and acute wounds, such as:
- Partial thickness (second degree) burns;
- Diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed etiology) and pressure ulcers/sores (partial & full thickness);
- Surgical wounds
- Traumatic wounds;
- Wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites;
- Abrasions;
- Lacerations;
- Minor Cuts;
- Minor scalds and burns.
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/K123481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123481: Aquacel AG Foam Hydrofiber Foam Dressing with Silver, Adhesive and Non Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123481
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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