510(k) · Cleared
ClearedCurad Antibacterial Bandage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · FRO Dressing, Wound, Drug
Cleared on Apr 12, 2012 after a 129-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Apr 12, 2012
- Review
- 129 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 5 citing it directly.
- This deviceK113583 Curad Antibacterial BandageMedline Industries, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK232333 Anti-bacterial bandageJinhua Jingdi Medical Supplies Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK221570 Antibacterial bandageAllmed Medical Products Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK221311 Antibacterial BandageWinner Medical Co., Ltd. · 2023
- Descendant · cites it directly · 0 of its ownK201324 Antibacterial BandageJiangsu Excellence Medical Supplies Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK200821 anti-bacterial bandagePlanet (Suzhou) Medical Products Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K232333Anti-bacterial bandageJinhua Jingdi Medical Supplies Co., Ltd. · 2024 · cites it directly0descendants
- K221570Antibacterial bandageAllmed Medical Products Co., Ltd. · 2023 · cites it directly0descendants
- K221311Antibacterial BandageWinner Medical Co., Ltd. · 2023 · cites it directly0descendants
- K201324Antibacterial BandageJiangsu Excellence Medical Supplies Co., Ltd. · 2021 · cites it directly0descendants
- K200821anti-bacterial bandagePlanet (Suzhou) Medical Products Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K113583 | Curad Antibacterial Bandage | Medline Industries, Inc. | 2012 | — |
| +1 | K232333 | Anti-bacterial bandage | Jinhua Jingdi Medical Supplies Co., Ltd. | 2024 | — |
| +1 | K221570 | Antibacterial bandage | Allmed Medical Products Co., Ltd. | 2023 | — |
| +1 | K221311 | Antibacterial Bandage | Winner Medical Co., Ltd. | 2023 | — |
| +1 | K201324 | Antibacterial Bandage | Jiangsu Excellence Medical Supplies Co., Ltd. | 2021 | — |
| +1 | K200821 | anti-bacterial bandage | Planet (Suzhou) Medical Products Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
5 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, K232333 (Jinhua Jingdi Medical Supplies Co., Ltd., 2024) has gone furthest, with 0 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. 2012, 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?
Antibacterial bandages are to be applied topically to the skin to help prevent infection in minor cuts, scrapes and burns.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K113583 · printed Nov 4, 2026
Cite this page
510(k) Report. “K113583: Curad Antibacterial Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K113583
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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