510(k) · Cleared
ClearedSorbact Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abigo Medical AB · FRO Dressing, Wound, Drug
Cleared on Apr 19, 2007 as substantially equivalent to K052696 (Covalon Technologies, Ltd., 2006) and 1 other predicate after a 196-day review. Its family tree reaches back 2 generations to 2000. 4 later devices descend from it.
- Decided
- Apr 19, 2007
- Review
- 196 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K002599 (2000). 6 ancestors in all, the oldest K940414 (1994). 4 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK002599 Modification to Acryderm Silver Antimicrobial Wound Dressing, Models…Acrymed, Inc. · 2000
- 1 generation backK052696 Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingCovalon Technologies, Ltd. · 2006
- This deviceK063059 Sorbact Wound DressingAbigo Medical AB · 2007
- Descendant · cites it directly · 1 of its ownK143151 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive…Bsn Medical GmbH · 2015
- Descendant · cites it directly · 0 of its ownK171225 Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017
- Descendant · cites it directly · 0 of its ownK153674 Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016
- Descendant · cites it directly · 0 of its ownK100591 SorbactAbigo Medical AB · 2011
Most influential descendants
Showing 4 of 4 · See all- K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact…Bsn Medical GmbH · 2015 · cites it directly1descendant
- K171225Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017 · cites it directly0descendants
- K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016 · cites it directly0descendants
- K100591SorbactAbigo Medical AB · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K002599 | Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041… | Acrymed, Inc. | 2000 | — |
| −1 | K052696 | Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing | Covalon Technologies, Ltd. | 2006 | — |
| 0 (this device) | K063059 | Sorbact Wound Dressing | Abigo Medical AB | 2007 | — |
| +1 | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact… | Bsn Medical GmbH | 2015 | — |
| +1 | K171225 | Sorbact Wound Dressing-Ribbon Gauze | Abigo Medical AB | 2017 | — |
| +1 | K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Abigo Medical AB | 2016 | — |
| +1 | K100591 | Sorbact | Abigo Medical AB | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K052696 | Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingSummary page 1…secondary intent). D. Devices to Which the New Device is Substantially Equivalent: ColActiveAG Antimicrobial Gel Sheet Dressing (K052696) Triosyn T40 Antimicrobial Wound Dressing (K051542) II. Device Description: Sorbact® Wound Dressi… | 2006 |
| * | K051542 | Triosyn T40 Antimicrobial Wound DressingSummary page 1…New Device is Substantially Equivalent: ColActiveAG Antimicrobial Gel Sheet Dressing (K052696) Triosyn T40 Antimicrobial Wound Dressing (K051542) II. Device Description: Sorbact® Wound Dressings are sterile bandages that attract and capture water-repelling… | 2006 |
What descends from it? (4)
4 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 7 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K143151 (Bsn Medical GmbH, 2015) has gone furthest, with 1 descendant 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. 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?
Rx: Sorbact® Wound Dressings are intended for use in the management of moderate to heavily exudating partial to full thickness wounds (including clean, colonized, contaminated or infected wounds) and to bind hydrophobic microbes. The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
Sorbact® Wound Dressings are intended for over-the-counter use in the management of draining minor wounds and to attract and bind water repelling germs. The dressings may be used on minor scrapes, cuts, sores and burns
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/K063059 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063059: Sorbact Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063059
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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