510(k) · Cleared
ClearedSilver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)
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 Sep 4, 2009 as substantially equivalent to K080383 (Convatec, A Division of E.R. Squibb & Sons, LLC, 2008) after a 214-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Sep 4, 2009
- Review
- 214 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K914604 (1992). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 deviceK090254 Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat)Convatec, A Division of E.R. Squibb & Sons, LLC · 2009
- Descendant · cites it directly · 0 of its ownK102212 D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver…Vascular Solutions, Inc. · 2011
Most influential descendants
Showing 1 of 1 · See all- K102212D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix SilverVascular Solutions, Inc. · 2011 · cites it directly0descendants
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) | K090254 | Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat) | Convatec, A Division of E.R. Squibb & Sons, LLC | 2009 | — |
| +1 | K102212 | D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix… | Vascular Solutions, Inc. | 2011 | — |
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 |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K080383 | Aquacel Hydrofiber Wound Dressing and AG Hydrofiber DressingSummary page 1…, Wound, Drug Device Class: Unclassified Product Code: FRO Substantially Equivalent Device: AQUACEL Ag Hydrofiber® Wound Dressing - K080383 Silver Hydrofiber® Reinforced with Nylon. Wound Dressings is a soft, sterile, non-woven flat dressing composed of hydrocolloid f… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102212 | D-Stat Dry Silver; D-Stat Dry Clear Silver; D-Stat Dry Wrap Silver; Thrombix Silver | 2011 | 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 17 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K102212 (Vascular Solutions, Inc., 2011) has gone furthest, with 0 descendants of its own.
- 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. 2009, 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, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of: 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 and full thickness); Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection…
Read the full statement (140 words)
Under the supervision of a healthcare professional, the Silver Hydrofiber® Wound Dressing Reinforced with Nylon may be used for the management of:
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 and full thickness);
Wounds as an effective barrier to bacterial penetration of the dressing as this may help reduce infection;
Surgical wounds left to heal by secondary intention such as dehisced surgical incisions;
Surgical wounds that heal by primary intention 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 as stated in the FDA summary.
https://510kreport.com/device/K090254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090254: Silver Impregnated Hydrofiber Dressing Reinforced with Nylon (Flat).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090254
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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