510(k) · Cleared
ClearedExsalt SD7 Wound Dressing with Adhesive Backing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Exciton Technologies, Inc. · FRO Dressing, Wound, Drug
Cleared on Mar 26, 2014 as substantially equivalent to K103067 (Exciton Technologies, Inc., 2011) after a 104-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Mar 26, 2014
- Review
- 104 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001519 (2000). No later device cites it as a predicate yet.
- Root · 3 generations backK001519 Acticoat 7 DressingWestaim Biomedical, Inc. · 2000
- 2 generations backK083870 Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2009
- 1 generation backK103067 Exsalt SD7 Wound DressingExciton Technologies, Inc. · 2011
- This deviceK133775 Exsalt SD7 Wound Dressing with Adhesive BackingExciton Technologies, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001519 | Acticoat 7 Dressing | Westaim Biomedical, Inc. | 2000 | — |
| −2 | K083870 | Exsalt SD7 Wound Dressing | Exciton Technologies, Inc. | 2009 | — |
| −1 | K103067 | Exsalt SD7 Wound Dressing | Exciton Technologies, Inc. | 2011 | — |
| 0 (this device) | K133775 | Exsalt SD7 Wound Dressing with Adhesive Backing | Exciton Technologies, Inc. | 2014 | — |
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 |
|---|---|---|---|
| * | K103067 | Exsalt SD7 Wound DressingSummary page 2…quivalence The labeled indications of the exsaltO SD7 Wound Dressing with Adhesive Backing are equivalent to those of the predicate device, exsaltG® SD7 Wound Dressing (K1 03067). The directions for use of the exsalt@® SD7 Wound Dressing with Adhesive Backing have been modified from the predicate by the re… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 2 companies; a new generation was cleared every 2.9 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K103067.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
The exsalt SD7 Wound Dressing with Adhesive Backing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt SD7 Wound Dressing with Adhesive Backing provides an antibacterial barrier that inhibits bacterial growth in the dressing pad for up to 7 days.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133775 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133775: Exsalt SD7 Wound Dressing with Adhesive Backing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133775
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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