510(k) · Cleared
ClearedSS Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech, Inc. · KGN Wound Dressing With Animal-Derived Material (S)
Cleared on May 30, 2002 as substantially equivalent to K993948 (Cook Biotech, Inc., 2000) and 2 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1988. 5 later devices descend from it.
- Decided
- May 30, 2002
- Review
- 85 days
- Class
- Class U
- Product code
- KGN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K881854 (1988). 9 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 2 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 1 generation backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- This deviceK020732 SS MatrixCook Biotech, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK061474 Collawound DressingCollamatrix Co., Inc. · 2006
- Descendant · 2 generations on · 2 of its ownK090894 Collawound Wound DressingCollamatrix Co., Inc. · 2009
- Descendant · 3 generations on · 1 of its ownK162348 ABCcolla Collagen MatrixAcro Biomedical Co., Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK233378 ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd. · 2024
- Descendant · cites it directly · 0 of its ownK140820 Xenomem Wound MatrixViscus Biologics, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K061474Collawound DressingCollamatrix Co., Inc. · 2006 · cites it directly3descendants
- K090894Collawound Wound DressingCollamatrix Co., Inc. · 2009 · 2 generations on2descendants
- K162348ABCcolla Collagen MatrixAcro Biomedical Co., Ltd. · 2017 · 3 generations on1descendant
- K233378ABCcolla® Collagen ADM ScaffoldAcro Biomedical Co., Ltd. · 2024 · 4 generations on0descendants
- K140820Xenomem Wound MatrixViscus Biologics, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −2 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −1 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| 0 (this device) | K020732 | SS Matrix | Cook Biotech, Inc. | 2002 | — |
| +1 | K061474 | Collawound Dressing | Collamatrix Co., Inc. | 2006 | — |
| +2 | K090894 | Collawound Wound Dressing | Collamatrix Co., Inc. | 2009 | — |
| +3 | K162348 | ABCcolla Collagen Matrix | Acro Biomedical Co., Ltd. | 2017 | — |
| +4 | K233378 | ABCcolla® Collagen ADM Scaffold | Acro Biomedical Co., Ltd. | 2024 | — |
| +1 | K140820 | Xenomem Wound Matrix | Viscus Biologics, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 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? (3)
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 |
|---|---|---|---|
| * | K993948 | Sis Wound Dressing IISummary page 1…he SS Matrix™ is similar to predicate collagen-based wound dressings that are currently marketed for the management of wounds including the SIS Wound Dressing IT (D.C. #K993948) manufactured by Cook Biotech Incorporated, the FIBRACOL* Plus Collagen Wound Dressing (D.C. #K982597) manufactured by Johnson &… | 2000 |
| * | K982597 | Fibrcol Plus Collagen Wound Dressing with AlginateSummary page 1…the management of wounds including the SIS Wound Dressing IT (D.C. #K993948) manufactured by Cook Biotech Incorporated, the FIBRACOL* Plus Collagen Wound Dressing (D.C. #K982597) manufactured by Johnson & Johnson Medical, and the EZ Derm™ Biosynthetic Wound Dressing (D.C. #K935189) manufactured by Brennen… | 1998 |
| * | K935189 | E-Z Derm Biosynthetic Wound DressingSummary page 1…h Incorporated, the FIBRACOL* Plus Collagen Wound Dressing (D.C. #K982597) manufactured by Johnson & Johnson Medical, and the EZ Derm™ Biosynthetic Wound Dressing (D.C. #K935189) manufactured by Brennen Medical Incorporated. Device Description: The SS Matrix™ is primarily composed of porcine collagen that… | 1994 |
What descends from it? (5)
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K061474 (Collamatrix Co., Inc., 2006) has gone furthest, with 3 descendants of its own.
- 9 other devices also cite its predicate K993948.
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 | — |
What is it indicated for?
The SS Matrix is intended for the management of wounds including:
Partial and full-thickness wounds
Pressure ulcers
Venous ulcers
Diabetic ulcers
Chronic vascular ulcers
Tunneled/undermined wounds
Surgical wounds (donor sites/grafts, post-Moh’s surgery, post-laser surgery, podiatric, wound dehiscence)
Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
Draining wounds.
The device is intended for one-time use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K020732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020732: SS Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020732
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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