510(k) · Cleared
ClearedAwbat-S, Awbat-D, Awbat-M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aubrey, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on Feb 6, 2009 after a 130-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Feb 6, 2009
- Review
- 130 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK082869 Awbat-S, Awbat-D, Awbat-MAubrey, Inc. · 2009
- Descendant · cites it directly · 2 of its ownK091863 Awbat-S Plus, Awbat-D Plus, Awbat-M PlusAubrey, Inc. · 2010
- Descendant · 2 generations on · 1 of its ownK153678 PermeaDerm B, PermeaDerm CW, and PermeaDerm GlovePermeaderm, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK212579 FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See all- K091863Awbat-S Plus, Awbat-D Plus, Awbat-M PlusAubrey, Inc. · 2010 · cites it directly2descendants
- K153678PermeaDerm B, PermeaDerm CW, and PermeaDerm GlovePermeaderm, Inc. · 2016 · 2 generations on1descendant
- K212579FortiShield (Biosynthetic Wound Matrix)Organogenesis, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082869 | Awbat-S, Awbat-D, Awbat-M | Aubrey, Inc. | 2009 | — |
| +1 | K091863 | Awbat-S Plus, Awbat-D Plus, Awbat-M Plus | Aubrey, Inc. | 2010 | — |
| +2 | K153678 | PermeaDerm B, PermeaDerm CW, and PermeaDerm Glove | Permeaderm, Inc. | 2016 | — |
| +1 | K212579 | FortiShield (Biosynthetic Wound Matrix) | Organogenesis, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
| 2023 | 1 | 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 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? (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 |
|---|---|---|---|
| * | — | Biobrane® Named without a submission number |
What descends from it? (3)
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, K091863 (Aubrey, Inc., 2010) has gone furthest, with 2 descendants 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. 2009, this device’s year, is highlighted.
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 | — |
What is it indicated for?
AWBAT-S is intended for clean Superfical burn wounds.
AWBAT-D is intended for Donor sites after hemostasis has been established.
AWBAT-M is to be used as protective covering for Meshed autografts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082869 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082869: Awbat-S, Awbat-D, Awbat-M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082869
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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