510(k) · Cleared
ClearedDuoderm Control Gel Formula Border Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, Ltd. · FRO Dressing, Wound, Drug
Cleared on Dec 23, 1997 after an 88-day review. The FDA summary names its predicate without a number. 110 later devices descend from it.
- Decided
- Dec 23, 1997
- Review
- 88 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
110 later devices descend from it, 3 citing it directly.
- This deviceK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- Descendant · cites it directly · 107 of its ownK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- Descendant · 2 generations on · 106 of its ownK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- Descendant · 2 generations on · 97 of its ownK040019 SilversealNoble Fiber Technologies · 2004
- Descendant · 3 generations on · 73 of its ownK063069 Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007
- Descendant · 4 generations on · 66 of its ownK073547 Anasept Antimicrobial Skin and Wound Cleansers; Anasept…Anacapa Technologies, Inc. · 2008
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 110 · See all- K983362NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998 · cites it directly107descendants
- K022995Collatek HydrogelBiocore Medical Technologies, Inc. · 2002 · 2 generations on106descendants
- K040019SilversealNoble Fiber Technologies · 2004 · 2 generations on97descendants
- K063069Silvaklenz Skin and Wound Clenser SolutionMedical Molecular Therapuetics, LLC · 2007 · 3 generations on73descendants
- K073547Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and Wound GelAnacapa Technologies, Inc. · 2008 · 4 generations on66descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| +1 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| +2 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| +2 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| +3 | K063069 | Silvaklenz Skin and Wound Clenser Solution | Medical Molecular Therapuetics, LLC | 2007 | — |
| +4 | K073547 | Anasept Antimicrobial Skin and Wound Cleansers; Anasept Antimicrobial Skin and… | Anacapa Technologies, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 9 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 7 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | — | SignaDRESS Hydrocolloid Dressing Named without a submission number | |
| † | K901155 | Duoderm* Control Gel Formula Border Dressing | 1990 |
What descends from it? (110)
See all 1103 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?
- Of its descendants, K983362 (Johnson & Johnson Medical, Inc., 1998) has gone furthest, with 107 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?
DuoDERM CGF Control Gel Formula Border Dressing is indicated for use on chronic wounds such as pressure ulcers, leg ulcers, diabetic ulcers and acute wounds such as superficial wounds (e.g. minor abrasions), second degree burns and donor sites. DuoDERM CGF Control Gel Formula Border Dressing provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement
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/K973688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973688: Duoderm Control Gel Formula Border Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973688
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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