510(k) · Cleared
ClearedHydroderm Breathable Transparent Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilshire Medical Products · MGP Dressing, Wound And Burn, Occlusive
Cleared on Feb 2, 1994 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- Feb 2, 1994
- Review
- 57 days
- Class
- Class U
- Product code
- MGP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK935796 Hydroderm Breathable Transparent DressingWilshire Medical Products · 1994
- Descendant · cites it directly · 4 of its ownK973312 Transparent Film Dressing, Intelligent Film DressingInnovative Technologies, Ltd. · 1997
- Descendant · 2 generations on · 3 of its ownK020781 Wet ChamberKinetic Concepts, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK060046 DermastreamEnzysurge, Ltd. · 2006
- Descendant · 3 generations on · 0 of its ownK091133 Aplion Topical Care SystemAplion Medical,Llc · 2009
- Descendant · 2 generations on · 0 of its ownK043063 Oxyband Wound DressingOxyband Technologies, Inc. · 2005
Most influential descendants
Showing 5 of 5 · See all- K973312Transparent Film Dressing, Intelligent Film DressingInnovative Technologies, Ltd. · 1997 · cites it directly4descendants
- K020781Wet ChamberKinetic Concepts, Inc. · 2002 · 2 generations on3descendants
- K060046DermastreamEnzysurge, Ltd. · 2006 · 3 generations on1descendant
- K091133Aplion Topical Care SystemAplion Medical,Llc · 2009 · 3 generations on0descendants
- K043063Oxyband Wound DressingOxyband Technologies, Inc. · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935796 | Hydroderm Breathable Transparent Dressing | Wilshire Medical Products | 1994 | — |
| +1 | K973312 | Transparent Film Dressing, Intelligent Film Dressing | Innovative Technologies, Ltd. | 1997 | — |
| +2 | K020781 | Wet Chamber | Kinetic Concepts, Inc. | 2002 | — |
| +3 | K060046 | Dermastream | Enzysurge, Ltd. | 2006 | — |
| +3 | K091133 | Aplion Topical Care System | Aplion Medical,Llc | 2009 | — |
| +2 | K043063 | Oxyband Wound Dressing | Oxyband Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973312 | Transparent Film Dressing, Intelligent Film Dressing | 1997 | 4 |
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, K973312 (Innovative Technologies, Ltd., 1997) has gone furthest, with 4 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/K935796 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935796: Hydroderm Breathable Transparent Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935796
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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