510(k) · Cleared
ClearedDuoderm Hydroactive Gel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Bristol-Myers Squibb Co. · MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
Cleared on Dec 29, 1997 after an 84-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Dec 29, 1997
- Review
- 84 days
- Class
- Class U
- Product code
- MGQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK973806 Duoderm Hydroactive GelConvatec, A Bristol-Myers Squibb Co. · 1997
- Descendant · cites it directly · 3 of its ownK143058 PuraDerm Gel3-D Matrix, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK182681 AC5 Topical GelArch Therapeutics, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK193085 PuraDERM Gel3-D Matrix, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK190129 AC5 Topical GelArch Therapeutics, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K143058PuraDerm Gel3-D Matrix, Inc. · 2015 · cites it directly3descendants
- K182681AC5 Topical GelArch Therapeutics, Inc. · 2018 · cites it directly1descendant
- K193085PuraDERM Gel3-D Matrix, Inc. · 2020 · 2 generations on0descendants
- K190129AC5 Topical GelArch Therapeutics, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973806 | Duoderm Hydroactive Gel | Convatec, A Bristol-Myers Squibb Co. | 1997 | — |
| +1 | K143058 | PuraDerm Gel | 3-D Matrix, Inc. | 2015 | — |
| +1 | K182681 | AC5 Topical Gel | Arch Therapeutics, Inc. | 2018 | — |
| +2 | K193085 | PuraDERM Gel | 3-D Matrix, Inc. | 2020 | — |
| +2 | K190129 | AC5 Topical Gel | Arch Therapeutics, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 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 MGQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
What descends from it? (4)
2 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, K143058 (3-D Matrix, Inc., 2015) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MGQ devicesMGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGQ
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MGQ
Too few MGQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MGQ
4in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGQ
5in 2025
MAUDE reports naming product code MGQ, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 4 | 10 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DuoDERM Hydroactive Gel is designed for the hydration and management of partial and full thickness wounds such as pressure sores, leg ulcers, and diabetic ulcers. DuoDERM Hydroactive Gel provides a moist wound environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the secondary dressing without damaging newly formed tissue,
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/K973806 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973806: Duoderm Hydroactive Gel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973806
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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