510(k) · Cleared
ClearedAquacel Hydrofiber Wound Dressing and AG Hydrofiber 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 May 2, 2008 as substantially equivalent to K943258 (Convatec, A Division of E.R. Squibb & Sons, 1994) and 2 other predicates after an 80-day review. Its family tree reaches back 3 generations to 1992. 54 later devices descend from it.
- Decided
- May 2, 2008
- Review
- 80 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K914604 (1992). 5 ancestors in all. 54 later devices descend from it, 15 citing it directly.
- Root · 3 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 2 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 1 generation backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- This deviceK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- Descendant · cites it directly · 13 of its ownK122817 Silverlon Island Wound DressingArgentum Medical, LLC · 2014
- Descendant · cites it directly · 13 of its ownK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
- Descendant · 2 generations on · 5 of its ownK143001 Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014
- Descendant · cites it directly · 5 of its ownK121522 Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK183645 Silver High Performance DressingAdvanced Medical Solutions, Ltd. · 2019 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K122817Silverlon Island Wound DressingArgentum Medical, LLC · 2014 · cites it directly13descendants
- K121275Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberConvatec, Inc. · 2012 · cites it directly13descendants
- K143001Silverlon Island Wound Dressing, Silverlon Wound Pad DressingArgentum Medical · 2014 · 2 generations on5descendants
- K121522Polyfit Absorbing Antimicrobial Dressings (Otc)Polyremedy, Inc. · 2012 · cites it directly5descendants
- K183645Silver High Performance DressingAdvanced Medical Solutions, Ltd. · 2019 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −2 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −1 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| 0 (this device) | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| +1 | K122817 | Silverlon Island Wound Dressing | Argentum Medical, LLC | 2014 | — |
| +1 | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec, Inc. | 2012 | — |
| +2 | K143001 | Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing | Argentum Medical | 2014 | — |
| +1 | K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | Polyremedy, Inc. | 2012 | — |
| +1 | K183645 | Silver High Performance Dressing | Advanced Medical Solutions, Ltd. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 6 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 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? (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 |
|---|---|---|---|
| * | K943258 | Hydrocolloid Wound DressingSummary page 1…Class: Unclassified Product Code: FRO Substantially Equivalent Device: AQUACEL® Hydrofiber® Wound Dressing K943258, K982116, K063271 AQUACEL®Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon… | 1994 |
| * | K982116 | Aquacel Hydrofiber Wound DressingSummary page 1…Unclassified Product Code: FRO Substantially Equivalent Device: AQUACEL® Hydrofiber® Wound Dressing K943258, K982116, K063271 AQUACEL®Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing… | 1998 |
| * | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated…Summary page 1…classified Product Code: FRO Substantially Equivalent Device: AQUACEL® Hydrofiber® Wound Dressing K943258, K982116, K063271 AQUACEL®Ag Hydrofiber® (Silver Impregnated Antimicrobial Dressing) is a soft, sterile, non-woven pad or ribbon dressing composed… | 2007 |
What descends from it? (54)
See all 5415 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122817 | Silverlon Island Wound Dressing | 2014 | 13 |
| K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | 2012 | 13 |
| K121522 | Polyfit Absorbing Antimicrobial Dressings (Otc) | 2012 | 5 |
| K183645 | Silver High Performance Dressing | 2019 | 4 |
| K091034 | Aquacel AG Surgical | 2009 | 2 |
| K210466 | Silver Gelling Fiber Dressing | 2022 | 1 |
| K162508 | KerraCel Ag Gelling Fiber Silver Dressing | 2017 | 1 |
| K153756 | Microlyte Ag | 2016 | 1 |
| K103793 | Durafiber AG | 2011 | 1 |
| K100693 | Aquanova AG Super Absorbant Dressing, Aquanova AG Antimicrobial Dressing | 2010 | 1 |
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 16 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K122817 (Argentum Medical, LLC, 2014) has gone furthest, with 13 descendants of its own.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of: - Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection - Partial thickness (second degree) bums - Diabetic foot ulcers, leg ulcers (venous…
Read the full statement (298 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 healthcare professional, AQUACEL® Ag Hydrofiber Dressing may be used for the management of:
- Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection
- Partial thickness (second degree) bums
- 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 left to heal by secondary intention such as dehisced surgical incisions,
- Surgical wounds that heal by primary intent such as dermatological and surgical incisions (e.g., orthopedic and vascular)'
- Traumatic wounds
- Wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided and donor sites'
- Oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma
- Management of painful wounds
- Infected Wounds¹
For Over-the-Counter Use, AQUACEL® Hydrofiber® Wound Dressing may be used for:
- Abrasions
- Lacerations
- Minor cuts
- Minor scalds and bums
Under the supervision of a healthcare professional, AQUACEL® Hydrofiber® Wound Dressing may be used for the management of:
- Leg ulcers, pressure ulcers (Stage II-IV) and diabetic ulcers
- Surgical wounds (post-operative, donor sites, dermatological)
- Partial thickness (second degree) bums
- Traumatic or surgical wounds left to heal by secondary intention such as dehisced surgical incisions¹
- Surgical wounds that heal by primary intent, such as dermatological and surgical incisions (e.g., orthopedic and vascular)¹
- Traumatic wounds²
- Local management of wounds that are prone to bleeding, such as wounds that have been mechanically or surgically debrided and donor sites
- Management of painful wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080383 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080383: Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080383
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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