510(k) · Cleared
ClearedAQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec Limited · FRO Dressing, Wound, Drug
Cleared on Jul 20, 2018 as substantially equivalent to K121275 (Convatec, Inc., 2012) after a 232-day review. Its family tree reaches back 5 generations to 1992. 4 later devices descend from it.
- Decided
- Jul 20, 2018
- Review
- 232 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K914604 (1992). 7 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK914604 Mepitel Non-Adherent Silicone DressingMolnlycke Clinical Products AB · 1992
- 4 generations backK984371 Mepitel Non Adherent Silicone DressingMolnlycke Health Care, Inc. · 1999
- 3 generations backK063271 Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver…Convatec, A Division of E.R. Squibb & Sons, LLC · 2007
- 2 generations backK080383 Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingConvatec, A Division of E.R. Squibb & Sons, LLC · 2008
- 1 generation backK121275 Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening…Convatec, Inc. · 2012
- This deviceK173675 AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and…Convatec Limited · 2018
- Descendant · cites it directly · 0 of its ownK252167 Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver…Qingdao Bright Moon Biomedical Materials Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK222740 Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch…Speciality Fibres and Materials, Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK231953 Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber…Coloplast Corp. · 2024
- Descendant · cites it directly · 0 of its ownK213473 Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K252167Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber…Qingdao Bright Moon Biomedical Materials Co., Ltd. · 2025 · cites it directly0descendants
- K222740Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200…Speciality Fibres and Materials, Ltd. · 2024 · cites it directly0descendants
- K231953Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x…Coloplast Corp. · 2024 · cites it directly0descendants
- K213473Antimicrobial Gelling Fiber Dressing with PHMBAdvanced Medical Solutions, Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914604 | Mepitel Non-Adherent Silicone Dressing | Molnlycke Clinical Products AB | 1992 | — |
| −4 | K984371 | Mepitel Non Adherent Silicone Dressing | Molnlycke Health Care, Inc. | 1999 | — |
| −3 | K063271 | Aquacel Hydrofiber Dressing and Aquacel AG with Hydrofiber Silver Impregnated… | Convatec, A Division of E.R. Squibb & Sons, LLC | 2007 | — |
| −2 | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber Dressing | Convatec, A Division of E.R. Squibb & Sons, LLC | 2008 | — |
| −1 | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening Fiber | Convatec, Inc. | 2012 | — |
| 0 (this device) | K173675 | AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening… | Convatec Limited | 2018 | — |
| +1 | K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling… | Qingdao Bright Moon Biomedical Materials Co., Ltd. | 2025 | — |
| +1 | K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag… | Speciality Fibres and Materials, Ltd. | 2024 | — |
| +1 | K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572… | Coloplast Corp. | 2024 | — |
| +1 | K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | Advanced Medical Solutions, Ltd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K121275 | Aquacel AG Extra Hydrofiber Dressing with Silver and Strengthening FiberSummary page 5…ice Class: Unclassified Product Code: FRO Predicate Device: AQUACEL™ Ag EXTRA Hydrofiber™ Dressing, K121275 Device Description AQUACEL™ Ag+ EXTRA™ Enhanced Hydrofiber™ dressing with Silver and Strengthening Fiber is a soft, sterile dre… | 2012 |
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252167 | Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber… | 2025 | 0 |
| K222740 | Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200… | 2024 | 0 |
| K231953 | Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in); Biatain Fiber Ag (33572 - 10 cm x… | 2024 | 0 |
| K213473 | Antimicrobial Gelling Fiber Dressing with PHMB | 2023 | 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 26 years and passes through 5 companies; a new generation was cleared every 6.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K252167 (Qingdao Bright Moon Biomedical Materials Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K121275.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
AQUACEL™ Ag+ EXTRA Enhanced Dressing with Silver and Strengthening Fiber may be used for the management of: - Abrasions - Lacerations - Minor cuts - Minor scalds and burns Under the supervision of a healthcare professional; AQUACEL™ Ag+ EXTRA Enhanced Dressing with Silver and Strengthening Fiber 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…
Read the full statement (181 words)
AQUACEL™ Ag+ EXTRA Enhanced Dressing with Silver and Strengthening Fiber may be used for the management of:
- Abrasions
- Lacerations
- Minor cuts
- Minor scalds and burns
Under the supervision of a healthcare professional;
AQUACEL™ Ag+ EXTRA Enhanced Dressing with Silver and Strengthening Fiber 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) 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 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 wounds
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/K173675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173675: AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173675
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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