510(k) · Cleared
ClearedBiatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM
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 Feb 17, 2010 as substantially equivalent to K022416 (Coloplast Corp., 2003) and 1 other predicate after a 22-day review. Its family tree reaches back 5 generations to 1992. 11 later devices descend from it.
- Decided
- Feb 17, 2010
- Review
- 22 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K914579 (1992). 20 ancestors in all, the oldest K871166 (1987). 11 later devices descend from it, 5 citing it directly.
- Root · 5 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 4 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 3 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 2 generations backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- 1 generation backK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- This deviceK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- Descendant · cites it directly · 5 of its ownK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- Descendant · 2 generations on · 3 of its ownK160022 LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016
- Descendant · 3 generations on · 2 of its ownK170077 LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. · 2017
- Descendant · cites it directly · 2 of its ownK120828 Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4…Coloplast A/S · 2012
- Descendant · 4 generations on · 1 of its ownK223360 LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+…Huizhou Foryou Medical Devices Co., Ltd. · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · cites it directly5descendants
- K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016 · 2 generations on3descendants
- K170077LUOFUCON Silicone Ag Foam Dressing with BorderHuizhou Foryou Medical Devices Co., Ltd. · 2017 · 3 generations on2descendants
- K120828Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 InchesColoplast A/S · 2012 · cites it directly2descendants
- K223360LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −4 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −3 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −2 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| −1 | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | Coloplast Corp. | 2004 | — |
| 0 (this device) | K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | Coloplast A/S | 2010 | — |
| +1 | K140954 | Luofucon Silver PU Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
| +2 | K160022 | LUOFUCON Silicone Ag foam dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2016 | — |
| +3 | K170077 | LUOFUCON Silicone Ag Foam Dressing with Border | Huizhou Foryou Medical Devices Co., Ltd. | 2017 | — |
| +1 | K120828 | Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5… | Coloplast A/S | 2012 | — |
| +4 | K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial… | Huizhou Foryou Medical Devices Co., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K022416 | Contreet Foam Adhesive/Non-AdhesiveSummary page 2…to Coloplast'h currently marketed Contreet Adhesive and Non-Adhesive Foam Dressings and Contreet Cavity Foam Dressings, which were cleared under 510(k)s K022416 & K033869, respectively. Indications for Use Biatain Ag Foam Adhesive & Non-Adhesive Dressings are indicated for use in… | 2003 |
| * | K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Summary page 2…ast'h currently marketed Contreet Adhesive and Non-Adhesive Foam Dressings and Contreet Cavity Foam Dressings, which were cleared under 510(k)s K022416 & K033869, respectively. Indications for Use Biatain Ag Foam Adhesive & Non-Adhesive Dressings are indicated for use in the… | 2004 |
What descends from it? (11)
See all 115 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140954 | Luofucon Silver PU Antibacterial Foam Dressing | 2015 | 5 |
| K120828 | Biatain Silicone AG Foam Dressing - Adhesive: 3X3 Inches, 4X4 Inches, & 5X5 Inches | 2012 | 2 |
| K191819 | Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing… | 2020 | 1 |
| K254246 | LT Antibacterial Foam with Silver Dressing | 2026 | 0 |
| K191536 | Biatain Silicone Ag | 2020 | 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 18 years and passes through 5 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K140954 (Huizhou Foryou Medical Devices Co., Ltd., 2015) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K022416.
How does its category compare?
All FRO devicesFRO Dressing, Wound, Drug: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Ag Foam Adhesive & Non-Adhesive 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.
Biatain Ag Foam Non-Adhesive Dressings are additionally indicated for diabetic foot ulcers.
Biatain Ag Foam Cavity Dressings are indicated for deep wounds with moderate to high amounts of exudate.
Biatain Ag Foam Cavity Dressings are indicated for stage II, III and IV pressure ulcers, leg ulcers, diabetic foot ulcers and first or second degree burns with significant loss of tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100218: Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100218
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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