510(k) · Cleared
ClearedActisorb Silver 220 Antimicrobial Binding Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Johnson & Johnson Medical, Ltd. · FRO Dressing, Wound, Drug
Cleared on Feb 3, 2003 as substantially equivalent to K002896 (The Westaim Corp., 2001) after a 189-day review. Its family tree reaches back 3 generations to 1991. 12 later devices descend from it.
- Decided
- Feb 3, 2003
- Review
- 189 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K914575 (1991). 5 ancestors in all. 12 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK914575 Sorbsan Topical Wound Dressing (Modified)Dow B. Hickam, Inc. · 1991
- 2 generations backK983210 Algisite MSmith & Nephew, Inc. · 1998
- 1 generation backK002896 Acticoat Foam Dressing, Algisite M Calcium Alginate DressingThe Westaim Corp. · 2001
- This deviceK022483 Actisorb Silver 220 Antimicrobial Binding DressingJohnson & Johnson Medical, Ltd. · 2003
- Descendant · cites it directly · 6 of its ownK082333 Asap Wound Dressing GelAmerican Biotech Labs · 2009
- Descendant · 2 generations on · 2 of its ownK092826 Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009
- Descendant · cites it directly · 2 of its ownK032463 Curad Silver BandageBeiersdorf AG · 2004
- Descendant · 2 generations on · 1 of its ownK140483 Asap Otc Wound Dressing GelAbl Medical, LLC · 2014
- Descendant · 2 generations on · 1 of its ownK131176 Ross RU Skin DiscontinuitiesBiotd S.A. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K082333Asap Wound Dressing GelAmerican Biotech Labs · 2009 · cites it directly6descendants
- K092826Asap Antimicrobial Silver Wound Dressing GelAmerican Biotech Labs · 2009 · 2 generations on2descendants
- K032463Curad Silver BandageBeiersdorf AG · 2004 · cites it directly2descendants
- K140483Asap Otc Wound Dressing GelAbl Medical, LLC · 2014 · 2 generations on1descendant
- K131176Ross RU Skin DiscontinuitiesBiotd S.A. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K914575 | Sorbsan Topical Wound Dressing (Modified) | Dow B. Hickam, Inc. | 1991 | — |
| −2 | K983210 | Algisite M | Smith & Nephew, Inc. | 1998 | — |
| −1 | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate Dressing | The Westaim Corp. | 2001 | — |
| 0 (this device) | K022483 | Actisorb Silver 220 Antimicrobial Binding Dressing | Johnson & Johnson Medical, Ltd. | 2003 | — |
| +1 | K082333 | Asap Wound Dressing Gel | American Biotech Labs | 2009 | — |
| +2 | K092826 | Asap Antimicrobial Silver Wound Dressing Gel | American Biotech Labs | 2009 | — |
| +1 | K032463 | Curad Silver Bandage | Beiersdorf AG | 2004 | — |
| +2 | K140483 | Asap Otc Wound Dressing Gel | Abl Medical, LLC | 2014 | — |
| +2 | K131176 | Ross RU Skin Discontinuities | Biotd S.A. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K892831 | ACTISORB Plus Activated Charcoal Dressing with Silver Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | |
| * | K002896 | Acticoat Foam Dressing, Algisite M Calcium Alginate DressingSummary page 1…ed by Johnson & Johnson Medical Ltd., Gargrave, SKIWON, BD23 3RX, United Kingdom ACTICOAT Calcium Alginate Dressing (K002896) manufactured by Westaim Biomedical Inc, One Hampton Road, Suite 320., Exeter… | 2001 |
What descends from it? (12)
See all 124 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 12 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K082333 (American Biotech Labs, 2009) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K002896.
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 | — |
What is it indicated for?
ACTISORB* Silver 220 Antimicrobial Binding Dressing provides an effective barrier to bacterial penetration and for adsorbing offending odor resulting from wounds; the binding properties of the dressing trap bacteria, bacterial toxins and odor. ACTISORB" Silver 220 Antimicrobial Binding Dressing may help reduce infection in partial and full thickness wounds, including:
pressure ulcers
venous ulcers
diabetic ulcers
first and second-degree bums
donor sites
surgical wounds
ACTISORB* Silver 220 Antimicrobial Binding Dressing is suitable for use under compression bandaging.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022483 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022483: Actisorb Silver 220 Antimicrobial Binding Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022483
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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