510(k) · Cleared
ClearedCutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bsn Medical GmbH · FRO Dressing, Wound, Drug
Cleared on Jan 26, 2015 as substantially equivalent to K063059 (Abigo Medical AB, 2007) after an 84-day review. Its family tree reaches back 3 generations to 2000. 1 later device descends from it.
- Decided
- Jan 26, 2015
- Review
- 84 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K002599 (2000). 7 ancestors in all, the oldest K940414 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK002599 Modification to Acryderm Silver Antimicrobial Wound Dressing, Models…Acrymed, Inc. · 2000
- 2 generations backK052696 Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingCovalon Technologies, Ltd. · 2006
- 1 generation backK063059 Sorbact Wound DressingAbigo Medical AB · 2007
- This deviceK143151 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive…Bsn Medical GmbH · 2015
- Descendant · cites it directly · 0 of its ownK153674 Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016
Most influential descendants
Showing 1 of 1 · See all- K153674Sorbact Foam Gentle Border, Sorbact SuperabsorbentAbigo Medical AB · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K002599 | Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041… | Acrymed, Inc. | 2000 | — |
| −2 | K052696 | Covaclearag Collagen with Silver Antimicrobial Gel Sheet Dressing | Covalon Technologies, Ltd. | 2006 | — |
| −1 | K063059 | Sorbact Wound Dressing | Abigo Medical AB | 2007 | — |
| 0 (this device) | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact… | Bsn Medical GmbH | 2015 | — |
| +1 | K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | Abigo Medical AB | 2016 | — |
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 |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | K063059 | Sorbact Wound DressingSummary page 4…roactive B, Cutimed® Siltec Sorbact®) Classification: Unclassified Product Code: FRO Predicate Device(s): The subject device is equivalent to the following device: K063059, Sorbact® Wound Dressings, Abigo Medical AB Device Description: Cutimed® Sorbact® Wound Dressings combine Sorbact mesh (Sorbact… | 2007 |
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 |
|---|---|---|---|
| K153674 | Sorbact Foam Gentle Border, Sorbact Superabsorbent | 2016 | 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 15 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K153674 (Abigo Medical AB, 2016) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K063059.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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?
Cutimed® Sorbact® Hydroactive is indicated for use in the management of low to moderate exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds. Cutimed® Sorbact® Hydroactive B is indicated for use in the management of low to moderate exuding partial to full thickness wounds…
Read the full statement (133 words)
Cutimed® Sorbact® Hydroactive is indicated for use in the management of low to moderate exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Cutimed® Sorbact® Hydroactive B is indicated for use in the management of low to moderate exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
Cutimed® Siltec Sorbact® is indicated for use in the management of moderate to heavily exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic 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/K143151 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143151: Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143151
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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