510(k) · Cleared
ClearedContreet Foam Adhesive/Non-Adhesive
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 Feb 3, 2003 as substantially equivalent to K983173 (Coloplast Corp., 1998) and 2 other predicates after a 194-day review. Its family tree reaches back 2 generations to 1995. 32 later devices descend from it.
- Decided
- Feb 3, 2003
- Review
- 194 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K946245 (1995). 5 ancestors in all, the oldest K871166 (1987). 32 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK946245 Tielle* Hydropolymer DressingJohnson & Johnson International · 1995
- 1 generation backK983173 Biatain Foam Adhesive DressingColoplast Corp. · 1998
- This deviceK022416 Contreet Foam Adhesive/Non-AdhesiveColoplast Corp. · 2003
- Descendant · cites it directly · 17 of its ownK033869 Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004
- Descendant · cites it directly · 11 of its ownK100218 Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM…Coloplast A/S · 2010
- Descendant · cites it directly · 6 of its ownK062559 Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007
- Descendant · 2 generations on · 5 of its ownK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K033869Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)Coloplast Corp. · 2004 · cites it directly17descendants
- K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · cites it directly11descendants
- K062559Urgocell AG Antimicrobial Wound Dressing with SilverLaboratoires Urgo · 2007 · cites it directly6descendants
- K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 2 generations on5descendants
- K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946245 | Tielle* Hydropolymer Dressing | Johnson & Johnson International | 1995 | — |
| −1 | K983173 | Biatain Foam Adhesive Dressing | Coloplast Corp. | 1998 | — |
| 0 (this device) | K022416 | Contreet Foam Adhesive/Non-Adhesive | Coloplast Corp. | 2003 | — |
| +1 | 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 | — |
| +1 | K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | Laboratoires Urgo | 2007 | — |
| +2 | K140954 | Luofucon Silver PU Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
| +2 | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K983173 | Biatain Foam Adhesive DressingSummary page 1…ication name Dressing, wound and burn, occlusive (21CFR878.4020) Legally marketed device to which substantial equivalence is claimed Biatain Foam Adhesive Dressing (K983173) Biatain Foam Non-adhesive Dressing (K983163) Acticoat Moisture Control Dressing (KO10447) Description of the device Contreet F… | 1998 |
| * | K983163 | Biatain Foam DressingSummary page 1…lusive (21CFR878.4020) Legally marketed device to which substantial equivalence is claimed Biatain Foam Adhesive Dressing (K983173) Biatain Foam Non-adhesive Dressing (K983163) Acticoat Moisture Control Dressing (KO10447) Description of the device Contreet Foam Dressing is a wound dressing with silver… | 1998 |
| * | K010447 | Modification to Acticoat Foam Dressing | 2001 |
What descends from it? (32)
See all 327 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033869 | Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.) | 2004 | 17 |
| K100218 | Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CM | 2010 | 11 |
| K062559 | Urgocell AG Antimicrobial Wound Dressing with Silver | 2007 | 6 |
| K032742 | Silver Foam Wound Dressing | 2004 | 3 |
| K060832 | Retro-Tech Dressing | 2007 | 2 |
| K093188 | Afm Ultra AG Dressings | 2010 | 1 |
| K033164 | Abram's Multi-Density Polyurethane Foam Wound Dressing System | 2004 | 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 8 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K033869 (Coloplast Corp., 2004) has gone furthest, with 17 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 Contreet Foam is 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. Contreet Foam Non-adhesive is additionally indicated for diabetic foot ulcers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022416: Contreet Foam Adhesive/Non-Adhesive.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022416
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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