510(k) · Cleared
ClearedModification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acrymed, Inc. · FRO Dressing, Wound, Drug
Cleared on Sep 21, 2000 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 8 later devices descend from it.
- Decided
- Sep 21, 2000
- Review
- 31 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK002599 Modification to Acryderm Silver Antimicrobial Wound Dressing, Models…Acrymed, Inc. · 2000
- Descendant · cites it directly · 5 of its ownK052696 Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingCovalon Technologies, Ltd. · 2006
- Descendant · 2 generations on · 4 of its ownK063059 Sorbact Wound DressingAbigo Medical AB · 2007
- Descendant · cites it directly · 1 of its ownK153756 Microlyte AgImbed Biosciences, Inc. · 2016
- Descendant · 3 generations on · 1 of its ownK143151 Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive…Bsn Medical GmbH · 2015
- Descendant · 2 generations on · 0 of its ownK211943 Microlyte Ag/LidocaineImbed Biosciences · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K052696Covaclearag Collagen with Silver Antimicrobial Gel Sheet DressingCovalon Technologies, Ltd. · 2006 · cites it directly5descendants
- K063059Sorbact Wound DressingAbigo Medical AB · 2007 · 2 generations on4descendants
- K153756Microlyte AgImbed Biosciences, Inc. · 2016 · cites it directly1descendant
- K143151Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact…Bsn Medical GmbH · 2015 · 3 generations on1descendant
- K211943Microlyte Ag/LidocaineImbed Biosciences · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K063059 | Sorbact Wound Dressing | Abigo Medical AB | 2007 | — |
| +1 | K153756 | Microlyte Ag | Imbed Biosciences, Inc. | 2016 | — |
| +3 | K143151 | Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact… | Bsn Medical GmbH | 2015 | — |
| +2 | K211943 | Microlyte Ag/Lidocaine | Imbed Biosciences | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (8)
2 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?
- Of its descendants, K052696 (Covalon Technologies, Ltd., 2006) has gone furthest, with 5 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 | — |
https://510kreport.com/device/K002599 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002599: Modification to Acryderm Silver Antimicrobial Wound Dressing, Models 1041, 1042, 1043, 1044, 1045.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002599
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026