510(k) · Cleared
ClearedBiatain Foam Adhesive Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Corp. · FRO Dressing, Wound, Drug
Cleared on Dec 16, 1998 as substantially equivalent to K946245 (Johnson & Johnson International, 1995) after a 97-day review. Its family tree reaches back 1 generation to 1995. 33 later devices descend from it.
- Decided
- Dec 16, 1998
- Review
- 97 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K946245 (1995). 33 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK946245 Tielle* Hydropolymer DressingJohnson & Johnson International · 1995
- This deviceK983173 Biatain Foam Adhesive DressingColoplast Corp. · 1998
- Descendant · cites it directly · 32 of its ownK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
- Descendant · 2 generations on · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- Descendant · 2 generations on · 11 of its ownK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- Descendant · 2 generations on · 6 of its ownK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
- Descendant · 3 generations on · 5 of its ownK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K022416Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003 · cites it directly32descendants
- K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · 2 generations on17descendants
- K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · 2 generations on11descendants
- K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007 · 2 generations on6descendants
- K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K946245 | Tielle* Hydropolymer Dressing | Johnson & Johnson International | 1995 | — |
| 0 (this device) | K983173 | Biatain Foam Adhesive Dressing | Coloplast Corp. | 1998 | — |
| +1 | K022416 | Contreet Foam Adhesive/Non-Adhesive | Coloplast Corp. | 2003 | — |
| +2 | 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 | — |
| +2 | K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2007 | — |
| +3 | K140954 | Luofucon Silver PU Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2007 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 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? (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 |
|---|---|---|---|
| * | K946245 | Tielle* Hydropolymer DressingSummary page 2…iatain Foam Adhesive Dressing is similar in composition, function, and inten - ded use to other foam wound dressings, such as Tielle Hydropolymer Dressing (J&J Ltd. UK); K946245. A comparison is presented in the following Table. 12 €8 3173 510(k) SUMMARY Biatain Foam Adhesive Dressing Pa… | 1995 |
| † | K942283 | Comfeel Plus Transparent Dressing | 1994 |
What descends from it? (33)
See all 331 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022416 | Contreet Foam Adhesive/Non-Adhesive | 2003 | 32 |
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?
- Its one ancestor has no recall.
- Of its descendants, K022416 (Coloplast Corp., 2003) has gone furthest, with 32 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.
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 Biatain Foam Adhesive Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983173 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983173: Biatain Foam Adhesive Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983173
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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