510(k) · Cleared
ClearedDuo Derm Flex Hydroactive Dressings &
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Convatec, A Division of E.R. Squibb & Sons · FRO Dressing, Wound, Drug
Cleared on May 5, 1983 after a 59-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 65 devices in its family, counting itself, has a Class I recall. 64 later devices descend from it.
- Decided
- May 5, 1983
- Review
- 59 days
- Class
- Class U
- Product code
- FRO
- Recalls
- None
- Predicates
- 0
64 later devices descend from it, 2 citing it directly. 1 of the 65 devices in this family, counting this one, has a Class I recall.
- This deviceK830708 Duo Derm Flex Hydroactive Dressings &Convatec, A Division of E.R. Squibb & Sons · 1983
- Descendant · cites it directly · 60 of its ownK984413 Bionect HydrogelFidia Pharmaceutical Corp. · 1999
- Descendant · 2 generations on · 59 of its ownK020325 L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002
- Descendant · 3 generations on · 56 of its ownK090725 Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009
- Descendant · 4 generations on · 31 of its ownK100918 Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010
- Descendant · 5 generations on · 25 of its ownK123072 Vashe Wound Therapy SolutionPuricore, Inc. · 2013
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K123113 L.a.M. Imp Wound Gel2 generations on · 2012
Most influential descendants
Showing 5 of 64 · See all- K984413Bionect HydrogelFidia Pharmaceutical Corp. · 1999 · cites it directly60descendants
- K020325L.a.M. Ipm Wound GelL.A.M. Pharmaceutical, Corp. · 2002 · 2 generations on59descendants
- K090725Oculus Microcyn Wound GelOculus Innovative Sciences, Inc. · 2009 · 3 generations on56descendants
- K100918Vashe Wound Therapy System Model: 9000-0014Puricore, Inc. · 2010 · 4 generations on31descendants
- K123072Vashe Wound Therapy SolutionPuricore, Inc. · 2013 · 5 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K830708 | Duo Derm Flex Hydroactive Dressings & | Convatec, A Division of E.R. Squibb & Sons | 1983 | — |
| +1 | K984413 | Bionect Hydrogel | Fidia Pharmaceutical Corp. | 1999 | — |
| +2 | K020325 | L.a.M. Ipm Wound Gel | L.A.M. Pharmaceutical, Corp. | 2002 | — |
| +3 | K090725 | Oculus Microcyn Wound Gel | Oculus Innovative Sciences, Inc. | 2009 | — |
| +4 | K100918 | Vashe Wound Therapy System Model: 9000-0014 | Puricore, Inc. | 2010 | — |
| +5 | K123072 | Vashe Wound Therapy Solution | Puricore, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 4 | 0 |
| 2026 | 9 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (64)
See all 642 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K123113L.a.M. Imp Wound GelGlycobiosciences, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K984413 (Fidia Pharmaceutical Corp., 1999) has gone furthest, with 60 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 | — |
https://510kreport.com/device/K830708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K830708: Duo Derm Flex Hydroactive Dressings &.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K830708
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026