510(k) · Cleared
ClearedContreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.)
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 May 17, 2004 as substantially equivalent to K022416 (Coloplast Corp., 2003) and 3 other predicates after a 157-day review. Its family tree reaches back 4 generations to 1992. 17 later devices descend from it.
- Decided
- May 17, 2004
- Review
- 157 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K914579 (1992). 19 ancestors in all, the oldest K871166 (1987). 17 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK914579 Silver Foam Wound DressingVitaphore Corp. · 1992
- 3 generations backK955453 Acticoat Silver Coated DressingWestaim Technologies, Inc. · 1996
- 2 generations backK981299 Silverlon Contact Wound DressingArgentum International, LLC · 1998
- 1 generation backK984210 Silverlon Wound Packing StripsArgentum International, LLC · 1999
- This deviceK033869 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 · 2 generations on · 5 of its ownK140954 Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK123961 Sentrex Biosponge MPDBionova Medical, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK210949 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022
- Descendant · 3 generations on · 3 of its ownK160022 LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K100218Biatain Agfoam Dressings-Non-Adhesiv: 5X7CM, 10X10CM, 10X20CM,15X15CM & 20X20CMColoplast A/S · 2010 · cites it directly11descendants
- K140954Luofucon Silver PU Antibacterial Foam DressingHuizhou Foryou Medical Devices Co., Ltd. · 2015 · 2 generations on5descendants
- K123961Sentrex Biosponge MPDBionova Medical, Inc. · 2013 · cites it directly4descendants
- K210949Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2022 · 2 generations on3descendants
- K160022LUOFUCON Silicone Ag foam dressingHuizhou Foryou Medical Devices Co., Ltd. · 2016 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K914579 | Silver Foam Wound Dressing | Vitaphore Corp. | 1992 | — |
| −3 | K955453 | Acticoat Silver Coated Dressing | Westaim Technologies, Inc. | 1996 | — |
| −2 | K981299 | Silverlon Contact Wound Dressing | Argentum International, LLC | 1998 | — |
| −1 | K984210 | Silverlon Wound Packing Strips | Argentum International, LLC | 1999 | — |
| 0 (this device) | 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 | — |
| +2 | K140954 | Luofucon Silver PU Antibacterial Foam Dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2015 | — |
| +1 | K123961 | Sentrex Biosponge MPD | Bionova Medical, Inc. | 2013 | — |
| +2 | K210949 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2022 | — |
| +3 | K160022 | LUOFUCON Silicone Ag foam dressing | Huizhou Foryou Medical Devices Co., Ltd. | 2016 | — |
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 |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 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? (4)
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…m Cavity Dressing with silver Common Name Topical wound dressing with active ingredient Classificationname Unclassified claimed cl Contreet Foam (K022416) Antibacterial Alginate Dressing (K024298) Absorbent Antimicrobial Wound Dressing (KO13814) SilverIonT mWound Packing Strips (K98… | 2003 |
| * | K024298 | Antimicrobial Alginate DressingSummary page 2…Common Name Topical wound dressing with active ingredient Classificationname Unclassified claimed cl Contreet Foam (K022416) Antibacterial Alginate Dressing (K024298) Absorbent Antimicrobial Wound Dressing (KO13814) SilverIonT mWound Packing Strips (K984210) 6.:Descrtion of the device Contreet… | 2003 |
| * | K013814 | Absorbent Antimicrobial Wound Dressing | 2002 |
| * | K984210 | Silverlon Wound Packing StripsSummary page 2…assified claimed cl Contreet Foam (K022416) Antibacterial Alginate Dressing (K024298) Absorbent Antimicrobial Wound Dressing (KO13814) SilverIonT mWound Packing Strips (K984210) 6.:Descrtion of the device Contreet Foam Cavity Dressing is a highly absorbent foam cavity dressing with ionic silver as the ac… | 1999 |
What descends from it? (17)
See all 172 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 4 companies; a new generation was cleared every 4.3 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K100218 (Coloplast A/S, 2010) has gone furthest, with 11 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.
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?
Contreet Foam Cavity Dressing with Silver dressings are indicated for deep wounds with moderate to high amounts of exudate.
Contreet Foam Cavity Dressing with Silver is indicated for stage II,III and IVpressure 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/K033869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033869: Contreet Foam Cavity Dressing with Silver, Model 9628 (2X4 in.).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033869
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