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 Jan 13, 2023 as substantially equivalent to K181315 (Winner Medical Co., Ltd., 2019) and 1 other predicate after a 211-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Jan 13, 2023
- Review
- 211 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K895993 (1990). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK895993 Vitapatch Antimicrobial Catheter Securement DeviceVitaphore Corp. · 1990
- 2 generations backK990530 Kerlix MD Antimicrobial Gauze DressingThe Kendall Company, L.P. · 2000 · Recalled
- 1 generation backK070653 Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use…Tyco Healthcare · 2007
- This deviceK221755 Antimicrobial gauze sponge dressing; Antimicrobial super sponge…Winner Medical Co., Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K895993 | Vitapatch Antimicrobial Catheter Securement Device | Vitaphore Corp. | 1990 | — |
| −2 | K990530 | Kerlix MD Antimicrobial Gauze Dressing | The Kendall Company, L.P. | 2000 | 7 |
| −1 | K070653 | Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662 | Tyco Healthcare | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K181315 | Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial…Summary page 5…us niger (ATCC 16404). The effective inhibition of bacteria is 7 days. 5. Identification of Predicate Device Primary Predicate Device 510(k) Number: K181315 Product Name: Antimicrobial gauze sponge dressing Antimicrobial super sponge dressing Antimicrobial non-woven… | 2019 |
| * | K070653 | Kendall Kerlix Antimicrobial Super Sponge Dressing for Otc Use, Model 6662Summary page 5…crobial gauze sponge dressing Antimicrobial super sponge dressing Antimicrobial non-woven sponge dressing Secondary Predicate Device 510(k) Number: K070653 Product Name: Kendall Kerlix AMD Antimicrobial Gauze Dressing (OTC) The Antimicrobial gauze sponge dressing (OTC)/ An… | 2007 |
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 33 years and passes through 4 companies; a new generation was cleared every 10.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
Antimicrobial gauze sponge dressing, antimicrobial super sponge dressing, and antimicrobial non-woven sponge dressing are indicated to cover and protect, absorb wound exudate, and maintain moisture balance of minor cuts, minor abrasions, minor lacerations, and minor burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221755 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221755: 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/K221755
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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