510(k) · Cleared
ClearedAquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Division of E.R. Squibb & Sons, LLC · FRO Dressing, Wound, Drug
Cleared on Apr 16, 2007 as substantially equivalent to K984371 (Molnlycke Health Care, Inc., 1999) after a 168-day review. Its family tree reaches back 2 generations to 1992. 59 later devices descend from it.
- Decided
- Apr 16, 2007
- Review
- 168 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K914604 (1992). 59 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 1 generation backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- This deviceK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- Descendant · cites it directly · 54 of its ownK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- Descendant · 2 generations on · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
- Descendant · 2 generations on · 13 of its ownK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
- Descendant · 3 generations on · 5 of its ownK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
- Descendant · 2 generations on · 5 of its ownK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K080383Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008 · cites it directly54descendants
- K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · 2 generations on13descendants
- K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc. · 2012 · 2 generations on13descendants
- K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014 · 3 generations on5descendants
- K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −1 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| 0 (this device) | 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 | — |
| +2 | K122817 | Silverlon Island Wound Dressing | Argentum Medical, LLC | 2014 | — |
| +2 | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec, Inc. | 2012 | — |
| +3 | K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing | Argentum Medical | 2014 | — |
| +2 | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | Polyremedy, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K984371 | Mepitel Non Adherent Silicone DressingSummary page 1…NAC Device Class: Class I Substantially Equivalent Device: MEPITEL® Non Adherent Silicone Dressing K984371 AQUACEL® dressing is a soft, sterile, non-woven pad or ribbon dressing composed of hydrocolloid fibers (sodium carboxymethylcellu… | 1999 |
What descends from it? (59)
See all 595 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 15 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) has gone furthest, with 54 descendants of its own.
- 3 other devices also cite its predicate K984371.
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?
For Over-the-Counter use, Aquacel Hydrofiber Wound Dressing may be used for: - abrasions - lacerations - minor cuts - minor scalds and burns Under the supervision of a health care professional, Aquacel may be used for the management of. leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers surgical wounds (post-operative, donor sites, dermatological) second degree burns Aquacel may also be used for: management of surgical or traumatic wounds that…
Read the full statement (258 words)
For Over-the-Counter use, Aquacel Hydrofiber Wound Dressing may be used for:
- abrasions
- lacerations
- minor cuts
- minor scalds and burns
Under the supervision of a health care professional, Aquacel may be used for the management of.
leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers
surgical wounds (post-operative, donor sites, dermatological)
second degree burns
Aquacel may also be used for:
management of surgical or traumatic wounds that have been left to heal by secondary intention.
local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.
the management of painful wounds
For over-the-counter use, Aquacel-Ag may be used for:
- minor abrasions
- lacerations
- minor cuts
- minor scalds and burns
Under the supervision of a health care professional, Aquacel-Ag may be used for the management of.
- wounds as an effective barrier to bacterial penetration to help reduce infection;
- partial thickness (second degree) burns;
- diabetic foot ulcers, leg ulcers, (venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology) and pressure ulcers/sores (partial & full thickness);
- surgical wounds left to heal by secondary intent;
- traumatic wounds;
- wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided;
- oncology wounds with exudate, such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma, and angiosarcoma.
- the management of painful wounds
Aquacel Ag may be used on minimally exuding, non-exuding and dry wounds, as stated in the DIRECTIONS FOR USE.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063271: Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated Antimicrobial Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063271
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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