510(k) · Cleared
ClearedAntibacterial Adhesive Bandage
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
William Feinstein & Associates, Inc. · FRO Dressing, Wound, Drug
Cleared on Nov 5, 1999 after a 77-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Nov 5, 1999
- Review
- 77 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK992817 Antibacterial Adhesive BandageWilliam Feinstein & Associates, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK020318 Scivolutions Various Antibacterial BandagesScivolutions, Inc. · 2003
- Descendant · 2 generations on · 2 of its ownK150792 Next Science Wound GelNext Science, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK163188 Next Science Wound Gel (Rx)Next Science, LLC · 2017
- Descendant · 2 generations on · 1 of its ownK032983 Sensitive Skin Antibacterial BandagesScivolution, Inc. · 2004
- Descendant · 4 generations on · 0 of its ownK252028 LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K020318Scivolutions Various Antibacterial BandagesScivolutions, Inc. · 2003 · cites it directly5descendants
- K150792Next Science Wound GelNext Science, LLC · 2015 · 2 generations on2descendants
- K163188Next Science Wound Gel (Rx)Next Science, LLC · 2017 · 3 generations on1descendant
- K032983Sensitive Skin Antibacterial BandagesScivolution, Inc. · 2004 · 2 generations on1descendant
- K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992817 | Antibacterial Adhesive Bandage | William Feinstein & Associates, Inc. | 1999 | — |
| +1 | K020318 | Scivolutions Various Antibacterial Bandages | Scivolutions, Inc. | 2003 | — |
| +2 | K150792 | Next Science Wound Gel | Next Science, LLC | 2015 | — |
| +3 | K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | 2017 | — |
| +2 | K032983 | Sensitive Skin Antibacterial Bandages | Scivolution, Inc. | 2004 | — |
| +4 | K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020318 | Scivolutions Various Antibacterial Bandages | 2003 | 5 |
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, K020318 (Scivolutions, Inc., 2003) 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 | — |
What is it indicated for?
Antibacterial Adhesive Bandages are to be applied to the skin for topical application. The bandages help prevent infection with minor cuts and scrapes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K992817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992817: Antibacterial Adhesive Bandage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992817
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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