510(k) · Cleared
ClearedBiatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 Inches
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · FRO Dressing, Wound, Drug
Cleared on Apr 5, 2012 as substantially equivalent to K100218 (Coloplast A/S, 2010) after a 17-day review. Its family tree reaches back 6 generations to 1992. 2 later devices descend from it.
- Decided
- Apr 5, 2012
- Review
- 17 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K914579 (1992). 21 ancestors in all, the oldest K871166 (1987). 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 5 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 4 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 3 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 2 generations backK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- 1 generation backK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- This deviceK120828 Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4…Coloplast A/S · 2012
- Descendant · cites it directly · 1 of its ownK191819 Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone…Winner Medical Co., Ltd. · 2020
- Descendant · 2 generations on · 0 of its ownK221754 Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive…Winner Medical Co., Ltd. · 2023
Most influential descendants
Showing 2 of 2 · See all- K191819Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing…Winner Medical Co., Ltd. · 2020 · cites it directly1descendant
- K221754Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…Winner Medical Co., Ltd. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −5 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −4 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −3 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −2 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| −1 | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Coloplast A/S | 2010 | — |
| 0 (this device) | K120828 | Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5… | Coloplast A/S | 2012 | — |
| +1 | K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam… | Winner Medical Co., Ltd. | 2020 | — |
| +2 | 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 |
|---|---|---|
| 2020 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMSummary page 2…rrier polyurethane (PU) film); a Center part (Soft, absorbing polyurethane (PU) antimicrobial foam (same Biatain Ag foam from Coloplast cleared via K100218) pads adhered to the top film with hot melt acrylic adhesive to avoid delamination when wet); a Border part (Perforate… | 2010 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing… | 2020 | 1 |
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 20 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K191819 (Winner Medical Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K100218.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120828 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120828: Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 Inches.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120828
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