510(k) · Cleared
ClearedAbsorbent Antimicrobial Wound 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 · FRO Dressing, Wound, Drug
Cleared on Jun 21, 2002 after a 217-day review. The FDA summary names its predicate without a number. 68 later devices descend from it.
- Decided
- Jun 21, 2002
- Review
- 217 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 12 citing it directly.
- This deviceK013814 Absorbent Antimicrobial Wound DressingConvatec, A Division of E.R. Squibb & Sons · 2002
- Descendant · cites it directly · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- Descendant · cites it directly · 16 of its ownK041316 Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004
- Descendant · cites it directly · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- Descendant · 2 generations on · 11 of its ownK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- Descendant · 2 generations on · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · cites it directly17descendants
- K041316Antimicrobial Alginate DressingAdvanced Medical Solutions, Ltd. · 2004 · cites it directly16descendants
- K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · cites it directly14descendants
- K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · 2 generations on11descendants
- K092689Manukapli Wound DressingManuka Medical Limited · 2010 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013814 | Absorbent Antimicrobial Wound Dressing | Convatec, A Division of E.R. Squibb & Sons | 2002 | — |
| +1 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| +1 | K041316 | Antimicrobial Alginate Dressing | Advanced Medical Solutions, Ltd. | 2004 | — |
| +1 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| +2 | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Coloplast A/S | 2010 | — |
| +2 | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 5 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 4 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | — | Acticoat Silver Coated Wound Dressing Named without a submission number |
What descends from it? (68)
See all 6812 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | 2004 | 17 |
| K041316 | Antimicrobial Alginate Dressing | 2004 | 16 |
| K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | 2008 | 14 |
| K024054 | Xylos Xcell Antimicrobial Dressing | 2003 | 7 |
| K033523 | Collagen-Orc Antimicrobial Matrix | 2004 | 4 |
| K070581 | Silver Alginate II Wound Dressing | 2007 | 3 |
| K063173 | Modification to Silver Alginate II Wound Dressing | 2006 | 3 |
| K032463 | Curad Silver Bandage | 2004 | 2 |
| K071442 | Suprasorb a +AG | 2008 | 1 |
| K111382 | Celver | 2012 | 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?
- Of its descendants, K033869 (Coloplast Corp., 2004) has gone furthest, with 17 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.
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, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns, Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in partial thickness (second degree) burns, diabetic foot ulcers, leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of…
Read the full statement (137 words)
For over-the-counter use, Absorbent Antimicrobial Wound Dressing may be used for minor abrasions, lacerations, minor cuts, minor scalds and burns,
Under the supervision of a health care professional, Absorbent Antimicrobial Wound Dressing is an effective barrier to bacterial penetration, which may help reduce infection in 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 and oncology wounds with exudate such as fungoides-cutaneous tumors, fungating carcinoma, cutaneous metastasis, Kaposi's sarcoma and angiosarcoma.
Absorbent Antimicrobial Wound Dressing 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/K013814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013814: Absorbent Antimicrobial Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013814
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026