510(k) · Cleared
ClearedDermagran Hydrophilic Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Derma Sciences, Inc. · MGP Dressing, Wound And Burn, Occlusive
Cleared on Nov 2, 1995 after a 17-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 16 later devices descend from it.
- Decided
- Nov 2, 1995
- Review
- 17 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK954738 Dermagran Hydrophilic Wound DressingDerma Sciences, Inc. · 1995
- Descendant · cites it directly · 15 of its ownK053538 Modification to Phytacare Alginate Hydrogel Wound FillerCurapharm, Inc. · 2006
- Descendant · 2 generations on · 14 of its ownK081584 Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008
- Descendant · 3 generations on · 10 of its ownK092689 Manukapli Wound DressingManuka Medical Limited · 2010
- Descendant · 4 generations on · 4 of its ownK121227 Manuka FillLinks Medical Products, Inc. · 2012
- Descendant · 5 generations on · 3 of its ownK131796 Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · Recalled
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K053538Modification to Phytacare Alginate Hydrogel Wound FillerCurapharm, Inc. · 2006 · cites it directly15descendants
- K081584Derma Sciences Otc Medihoney Dressings with Active Manuka HoneyDerma Sciences, Inc. · 2008 · 2 generations on14descendants
- K092689Manukapli Wound DressingManuka Medical Limited · 2010 · 3 generations on10descendants
- K121227Manuka FillLinks Medical Products, Inc. · 2012 · 4 generations on4descendants
- K131796Manuka Fill Wound DressingLinks Medical Products, Inc. · 2014 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K954738 | Dermagran Hydrophilic Wound Dressing | Derma Sciences, Inc. | 1995 | — |
| +1 | K053538 | Modification to Phytacare Alginate Hydrogel Wound Filler | Curapharm, Inc. | 2006 | — |
| +2 | K081584 | Derma Sciences Otc Medihoney Dressings with Active Manuka Honey | Derma Sciences, Inc. | 2008 | — |
| +3 | K092689 | Manukapli Wound Dressing | Manuka Medical Limited | 2010 | — |
| +4 | K121227 | Manuka Fill | Links Medical Products, Inc. | 2012 | — |
| +5 | K131796 | Manuka Fill Wound Dressing | Links Medical Products, Inc. | 2014 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2026 | 1 | 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.
Planning a device in MGP? 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053538 | Modification to Phytacare Alginate Hydrogel Wound Filler | 2006 | 15 |
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, K053538 (Curapharm, Inc., 2006) has gone furthest, with 15 descendants of its own.
How does its category compare?
All MGP devicesMGP Dressing, Wound And Burn, Occlusive: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MGP
FDA has decided no MGP device since 2007.
Median 510(k) review, days · MGP
Too few MGP 510(k)s in any year since 2007 to give a median.
Recalls per year · MGP
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MGP
8in 2024
MAUDE reports naming product code MGP, 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 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 52 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K954738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K954738: Dermagran Hydrophilic Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954738
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026