510(k) · Cleared
ClearedAntimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Winner Medical Co., Ltd. · FRO Dressing, Wound, Drug
Cleared on Feb 14, 2019 as substantially equivalent to K160872 (Global Health Solutions, LLC, 2016) after a 272-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Feb 14, 2019
- Review
- 272 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K041013 (2004). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK041013 Suile Ointment Wound DressingHedonist Biochemical Technologies Co., Ltd. · 2004
- 1 generation backK160872 PolyPlex Wound DressingGlobal Health Solutions, LLC · 2016
- This deviceK181315 Antimicrobial gauze sponge dressing, Antimicrobial super sponge…Winner Medical Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK221755 Antimicrobial gauze sponge dressing; Antimicrobial super sponge…Winner Medical Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221755Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…Winner Medical Co., Ltd. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041013 | Suile Ointment Wound Dressing | Hedonist Biochemical Technologies Co., Ltd. | 2004 | — |
| −1 | K160872 | PolyPlex Wound Dressing | Global Health Solutions, LLC | 2016 | — |
| 0 (this device) | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2019 | — |
| +1 | K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing… | Winner Medical Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K160872 | PolyPlex Wound DressingSummary page 5…lus niger. The effective inhibition of bacteria within the dressing is 7 days. 5. Identification of Predicate Device Predicate Device 510(k) Number: K160872 Product Name: PolyPlex Wound Dressing 6. Non-Clinical Test Conclusion Non clinical tests were conducted to verify t… | 2016 |
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 |
|---|---|---|---|
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial… | 2023 | 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 15 years and passes through 3 companies; a new generation was cleared every 12.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K221755 (Winner Medical Co., Ltd., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160872.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
It is intended for use as primary or secondary dressings for exuding wounds, surgical incisions, lacerations, abrasions, first and second degree burns, wound packing, donor sites, catheter sites, I.V. sites and central lines. Also may be used for securement of primary dressing. The antimicrobial activity of the PHMB and benzalkonium chloride in dressing helps resist bacterial colonization within the dressing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181315: Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181315
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