510(k) · Cleared
ClearedCurad Silver Bandage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beiersdorf AG · FRO Dressing, Wound, Drug
Cleared on Feb 10, 2004 as substantially equivalent to K023609 (Argentum International, LLC, 2003) and 4 other predicates after a 183-day review. Its family tree reaches back 4 generations to 1992. 2 later devices descend from it.
- Decided
- Feb 10, 2004
- Review
- 183 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K914579 (1992). 16 ancestors in all, the oldest K890354 (1989). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 1 generation backK023609 Silverlon Adhesive StripArgentum International, LLC · 2003
- This deviceK032463 Curad Silver BandageBeiersdorf AG · 2004
- Descendant · cites it directly · 0 of its ownK100580 Exsalt Wound DressingExciton Technologies, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK082910 CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver BandagesAso, LLC · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −1 | K023609 | Silverlon Adhesive Strip | Argentum International, LLC | 2003 | — |
| 0 (this device) | K032463 | Curad Silver Bandage | Beiersdorf AG | 2004 | — |
| +1 | K100580 | Exsalt Wound Dressing | Exciton Technologies, Inc. | 2010 | — |
| +1 | K082910 | CVS Silver Bandages, Walgreens Silver Bandages, Xyz Silver Bandages | Aso, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 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? (5)
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 |
|---|---|---|---|
| * | K023609 | Silverlon Adhesive StripSummary page 2…ge 1 KO324K3 P aqe 2E2 3. PREDICATE DEVICES CURAD® Silver Bandage is substantially equivalent to the following devices: Silver Strips™ Adhesive Strips K023609 Actisorb™ Silver 220 Antibacterial Binding Dressing K022483 Acticoat™ Composite Wound Dressing K002466 & K983833 Aquacel® Ag with… | 2003 |
| * | K022483 | Actisorb Silver 220 Antimicrobial Binding DressingSummary page 2…CURAD® Silver Bandage is substantially equivalent to the following devices: Silver Strips™ Adhesive Strips K023609 Actisorb™ Silver 220 Antibacterial Binding Dressing K022483 Acticoat™ Composite Wound Dressing K002466 & K983833 Aquacel® Ag with Hydrofiber Silver Impregnated K013814 Antimicrobial Dressin… | 2003 |
| * | K002466 | Acticoat Composite DressingSummary page 2…uivalent to the following devices: Silver Strips™ Adhesive Strips K023609 Actisorb™ Silver 220 Antibacterial Binding Dressing K022483 Acticoat™ Composite Wound Dressing K002466 & K983833 Aquacel® Ag with Hydrofiber Silver Impregnated K013814 Antimicrobial Dressing 4. DEVICE DESCRIPTION The CURAD® Silver… | 2001 |
| * | K983833 | Acticoat Composite Wound Dressing, Acticoat Composite Wound Dressing-AdhesiveSummary page 2…o the following devices: Silver Strips™ Adhesive Strips K023609 Actisorb™ Silver 220 Antibacterial Binding Dressing K022483 Acticoat™ Composite Wound Dressing K002466 & K983833 Aquacel® Ag with Hydrofiber Silver Impregnated K013814 Antimicrobial Dressing 4. DEVICE DESCRIPTION The CURAD® Silver Bandage i… | 1998 |
| * | K013814 | Absorbent Antimicrobial Wound DressingSummary page 2…s K023609 Actisorb™ Silver 220 Antibacterial Binding Dressing K022483 Acticoat™ Composite Wound Dressing K002466 & K983833 Aquacel® Ag with Hydrofiber Silver Impregnated K013814 Antimicrobial Dressing 4. DEVICE DESCRIPTION The CURAD® Silver Bandage is an adhesive bandage that includes silver in the wound… | 2002 |
What descends from it? (2)
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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K100580 (Exciton Technologies, Inc., 2010) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K023609.
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?
The CURAD® Silver Bandage is indicated for first aid to help in minor abrasions, cuts, lacerations, scrapes, and scalds.
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/K032463 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032463: Curad Silver Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032463
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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