510(k) · Cleared
ClearedAg Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border
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 May 14, 2020 as substantially equivalent to K120828 (Coloplast A/S, 2012) and 1 other predicate after a 314-day review. Its family tree reaches back 7 generations to 1992. 1 later device descends from it.
- Decided
- May 14, 2020
- Review
- 314 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K914579 (1992). 22 ancestors in all, the oldest K871166 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 6 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 5 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 4 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 3 generations backK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- 2 generations backK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- 1 generation backK120828 Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4…Coloplast A/S · 2012
- This deviceK191819 Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone…Winner Medical Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK221754 Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive…Winner Medical Co., Ltd. · 2023
Most influential descendants
Showing 1 of 1 · See all- K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…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 |
|---|---|---|---|---|---|
| −7 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −6 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −5 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −4 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −3 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| −2 | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Coloplast A/S | 2010 | — |
| −1 | K120828 | Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5… | Coloplast A/S | 2012 | — |
| 0 (this device) | K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam… | Winner Medical Co., Ltd. | 2020 | — |
| +1 | K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone… | Winner Medical Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 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? (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 |
|---|---|---|---|
| * | K120828 | Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesSummary page 4…: Unclassified; Product Code: FRO; Review Panel: General & Plastic Surgery; 4. Identification of Predicate Device Primary Predicate Device: 510(k) Number: K120828 1/6 510(K) Summary… | 2012 |
| * | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMSummary page 5…K191819 2 / 6 Product Name: Biatain Silicone Ag Foam Dressings Secondary Predicate Device: 510(k) Number: K100218 Product Name: Biatain Ag Foam Dressing 5. Device Description It is a sterile, single-use dressing, the foam layer conta… | 2010 |
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 |
|---|---|---|---|
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam… | 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 28 years and passes through 6 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K221754 (Winner Medical Co., Ltd., 2023) has gone furthest, with 0 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. 2020, 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 proposed devices are indicated for the management of moderately to highly exuding wounds, such as leg and foot ulcers, pressure ulcers, diabetic foot ulcers, skin abrasions, surgical wounds, donor sites, 1st and 2nd degree burns.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191819 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191819: Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191819
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