510(k) · Cleared
ClearedSorbact Wound Dressing-Ribbon Gauze
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 Aug 21, 2017 as substantially equivalent to K063059 (Abigo Medical AB, 2007) after a 117-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 21, 2017
- Review
- 117 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). No later device cites it as a predicate yet.
- 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 deviceK171225 Sorbact Wound Dressing-Ribbon GauzeAbigo Medical AB · 2017
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) | K171225 | Sorbact Wound Dressing-Ribbon Gauze | Abigo Medical AB | 2017 | — |
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 |
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…egulatory Class: Unclassified (Pre-amendment) Review Panel: General & Plastic Surgery Product Code: FRO Predicate Device: K063059, Sorbact® Wound Dressings – Ribbon Gauze ABIGO Medical AB Device Description: Sorbact® Ribbon Gauze i… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 5.4 years on median.
- None of the 7 ancestors has a recall.
- 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. 2017, 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?
Sorbact Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact Ribbon Gauze is indicated for shallow cavity wounds and fistulas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171225: Sorbact Wound Dressing-Ribbon Gauze.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171225
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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