510(k) · Cleared
ClearedSorbact
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 Jan 24, 2011 as substantially equivalent to K063059 (Abigo Medical AB, 2007) after a 328-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Jan 24, 2011
- Review
- 328 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 deviceK100591 SorbactAbigo Medical AB · 2011
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) | 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 |
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 1…d Dressing Classification Unclassified, Class 11medical device Regulation: Product FRO Code: Predicate Device Identification: Sorbact® Wound Dressing, K063059 Device Description: Sorbact gel Wound Dressings are sterile bandages that attract and capture water-repel… | 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 11 years and passes through 3 companies; a new generation was cleared every 3.8 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. 2011, 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?
OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding). The dressing may be used on minor scrapes, cuts, sores and burns.
Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to low exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100591: Sorbact.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100591
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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