510(k) · Cleared
ClearedScivolutions Various Antibacterial Bandages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scivolutions, Inc. · FRO Dressing, Wound, Drug
Cleared on Feb 3, 2003 as substantially equivalent to K992817 (William Feinstein & Associates, Inc., 1999) after a 369-day review. Its family tree reaches back 1 generation to 1999. 5 later devices descend from it.
- Decided
- Feb 3, 2003
- Review
- 369 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992817 (1999). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK992817 Antibacterial Adhesive BandageWilliam Feinstein & Associates, Inc. · 1999
- This deviceK020318 Scivolutions Various Antibacterial BandagesScivolutions, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK150792 Next Science Wound GelNext Science, LLC · 2015
- Descendant · 2 generations on · 1 of its ownK163188 Next Science Wound Gel (Rx)Next Science, LLC · 2017
- Descendant · cites it directly · 1 of its ownK032983 Sensitive Skin Antibacterial BandagesScivolution, Inc. · 2004
- Descendant · 3 generations on · 0 of its ownK252028 LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK082208 Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008
Most influential descendants
Showing 5 of 5 · See all- K150792Next Science Wound GelNext Science, LLC · 2015 · cites it directly2descendants
- K163188Next Science Wound Gel (Rx)Next Science, LLC · 2017 · 2 generations on1descendant
- K032983Sensitive Skin Antibacterial BandagesScivolution, Inc. · 2004 · cites it directly1descendant
- K252028LUOFUCON® Antimicrobial Wound GelHuizhou Foryou Medical Co., Ltd. · 2026 · 3 generations on0descendants
- K082208Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992817 | Antibacterial Adhesive Bandage | William Feinstein & Associates, Inc. | 1999 | — |
| 0 (this device) | K020318 | Scivolutions Various Antibacterial Bandages | Scivolutions, Inc. | 2003 | — |
| +1 | K150792 | Next Science Wound Gel | Next Science, LLC | 2015 | — |
| +2 | K163188 | Next Science Wound Gel (Rx) | Next Science, LLC | 2017 | — |
| +1 | K032983 | Sensitive Skin Antibacterial Bandages | Scivolution, Inc. | 2004 | — |
| +3 | K252028 | LUOFUCON® Antimicrobial Wound Gel | Huizhou Foryou Medical Co., Ltd. | 2026 | — |
| +2 | K082208 | Doctors Choice Slow Healing Bandage with Spray on Remover | Scivolutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K992817 | Antibacterial Adhesive BandageSummary page 5…me: SciVolutions Antibacterial Bandages Classification Name: Tape and bandage, Adhesive (with disinfectant) Predicate Device: K9928 17 William Feinstein and Associates, Inc. Anti-Bacterial Adhesive Band age Intended Use: Anti… | 1999 |
What descends from it? (5)
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?
- Its one ancestor has no recall.
- Of its descendants, K150792 (Next Science, LLC, 2015) has gone furthest, with 2 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 provide an antibacterial barrier for minor cuts and scrapes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020318: Scivolutions Various Antibacterial Bandages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020318
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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