510(k) · Cleared
ClearedSuile Ointment Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hedonist Biochemical Technologies Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Jul 7, 2004 after a 78-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jul 7, 2004
- Review
- 78 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK041013 Suile Ointment Wound DressingHedonist Biochemical Technologies Co., Ltd. · 2004
- Descendant · cites it directly · 4 of its ownK160872 PolyPlex Wound DressingGlobal Health Solutions, LLC · 2016
- Descendant · 2 generations on · 1 of its ownK181315 Antimicrobial gauze sponge dressing, Antimicrobial super sponge…Winner Medical Co., Ltd. · 2019
- Descendant · 3 generations on · 0 of its ownK221755 Antimicrobial gauze sponge dressing; Antimicrobial super sponge…Winner Medical Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK183681 Protego Antimicrobial Wound DressingGlobal Health Solutions (Dba Turn Therapeutics) · 2019
- Descendant · 2 generations on · 0 of its ownK171191 Hexagen DermGlobal Health Solutions, LLC · 2017
Most influential descendants
Showing 5 of 5 · See all- K160872PolyPlex Wound DressingGlobal Health Solutions, LLC · 2016 · cites it directly4descendants
- K181315Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial…Winner Medical Co., Ltd. · 2019 · 2 generations on1descendant
- K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…Winner Medical Co., Ltd. · 2023 · 3 generations on0descendants
- K183681Protego Antimicrobial Wound DressingGlobal Health Solutions (Dba Turn Therapeutics) · 2019 · 2 generations on0descendants
- K171191Hexagen DermGlobal Health Solutions, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041013 | Suile Ointment Wound Dressing | Hedonist Biochemical Technologies Co., Ltd. | 2004 | — |
| +1 | K160872 | PolyPlex Wound Dressing | Global Health Solutions, LLC | 2016 | — |
| +2 | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2019 | — |
| +3 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2023 | — |
| +2 | K183681 | Protego Antimicrobial Wound Dressing | Global Health Solutions (Dba Turn Therapeutics) | 2019 | — |
| +2 | K171191 | Hexagen Derm | Global Health Solutions, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 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)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160872 | PolyPlex Wound Dressing | 2016 | 4 |
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, K160872 (Global Health Solutions, LLC, 2016) has gone furthest, with 4 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?
The SUILE Ointment Wound Dressing is indicated for the management of 1st and 2nd degree burns, partial thickness wounds, donor sites and abrasions.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K041013 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041013: Suile Ointment Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041013
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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