510(k) · Cleared
ClearedBiobrane Brand Temporary Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Woodroof Laboratories, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on May 3, 1979 after a 51-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- May 3, 1979
- Review
- 51 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK790496 Biobrane Brand Temporary Wound DressingWoodroof Laboratories, Inc. · 1979
- Descendant · cites it directly · 1 of its ownK153678 PermeaDerm B, PermeaDerm CW, and PermeaDerm GlovePermeaderm, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK212579 FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K790496 | Biobrane Brand Temporary Wound Dressing | Woodroof Laboratories, Inc. | 1979 | — |
| +1 | K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove | Permeaderm, Inc. | 2016 | — |
| +2 | K212579 | FortiShield (Biosynthetic Wound Matrix) | Organogenesis, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2023 | 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 KGN? 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 KGN device
- #1 K231325 Corplex P / Theracor P / Allacor Pscore 17.9 · 8 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? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove | 2016 | 1 |
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, K153678 (Permeaderm, Inc., 2016) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KGN devicesKGN Wound Dressing With Animal-Derived Material (S): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KGN
15so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGN
162in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGN
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KGN
15in 2025
MAUDE reports naming product code KGN, 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 | 3 | 32 | 0 | 0 |
| 2008 | 6 | 87 | 0 | 1 |
| 2009 | 8 | 121 | 0 | 2 |
| 2010 | 4 | 175 | 0 | 3 |
| 2011 | 7 | 228 | 0 | 6 |
| 2012 | 8 | 123 | 0 | 4 |
| 2013 | 6 | 147 | 0 | 6 |
| 2014 | 5 | 188 | 0 | 12 |
| 2015 | 7 | 87 | 0 | 9 |
| 2016 | 4 | 164 | 0 | 6 |
| 2017 | 7 | 136 | 1 | 8 |
| 2018 | 6 | 148 | 3 | 15 |
| 2019 | 3 | 128 | 0 | 11 |
| 2020 | 5 | 279 | 0 | 17 |
| 2021 | 6 | 236 | 0 | 14 |
| 2022 | 12 | 246 | 0 | 13 |
| 2023 | 9 | 194 | 0 | 21 |
| 2024 | 13 | 83 | 0 | 15 |
| 2025 | 10 | 162 | 0 | 15 |
| 2026 | 15 | 174 | 0 | — |
https://510kreport.com/device/K790496 · printed Nov 4, 2026
Cite this page
510(k) Report. “K790496: Biobrane Brand Temporary Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K790496
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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