510(k) · Cleared
ClearedSensitive Skin Antibacterial Bandages
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Scivolution, Inc. · FRO Dressing, Wound, Drug
Cleared on Jun 1, 2004 as substantially equivalent to K020318 (Scivolutions, Inc., 2003) after a 251-day review. Its family tree reaches back 2 generations to 1999. 1 later device descends from it.
- Decided
- Jun 1, 2004
- Review
- 251 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K992817 (1999). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK992817 Antibacterial Adhesive BandageWilliam Feinstein & Associates, Inc. · 1999
- 1 generation backK020318 Scivolutions Various Antibacterial BandagesScivolutions, Inc. · 2003
- This deviceK032983 Sensitive Skin Antibacterial BandagesScivolution, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK082208 Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K082208Doctors Choice Slow Healing Bandage with Spray on RemoverScivolutions, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K992817 | Antibacterial Adhesive Bandage | William Feinstein & Associates, Inc. | 1999 | — |
| −1 | K020318 | Scivolutions Various Antibacterial Bandages | Scivolutions, Inc. | 2003 | — |
| 0 (this device) | K032983 | Sensitive Skin Antibacterial Bandages | Scivolution, Inc. | 2004 | — |
| +1 | 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 |
|---|---|---|
| 2008 | 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 |
|---|---|---|---|
| * | K020318 | Scivolutions Various Antibacterial BandagesSummary page 1…SciVolutions Antibacterial Gentle Care Bandages Classification Name: Tape and bandage, Adhesive (with disinfectant) Predicate Device: K020318 SciVolutions Various Antibacterial Bandages Indications for Use: SciVolutions Antibacterial Gentle Care Bandages are to… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082208 | Doctors Choice Slow Healing Bandage with Spray on Remover | 2008 | 0 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082208 (Scivolutions, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K020318.
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?
SciVolutions Antibacterial Gentle Care Bandages are to be applied to the skin for topical application for minor cuts and scrapes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032983 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032983: Sensitive Skin Antibacterial Bandages.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032983
Report an extraction error
Are you the manufacturer?
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