510(k) · Cleared
ClearedMirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Engineered Tissue Solutions, LLC · QSZ Absorbable Synthetic Wound Dressing
Cleared on Sep 15, 2016 as substantially equivalent to K071552 (Medline Industries, Inc., 2008) and 1 other predicate after a 153-day review. Its family tree reaches back 9 generations to 1985. 3 later devices descend from it.
- Decided
- Sep 15, 2016
- Review
- 153 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K842066 (1985). 77 ancestors in all, the oldest K810428 (1981). 3 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 5 generations between
- 3 generations backK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- 2 generations backK083266 Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009
- 1 generation backK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- This deviceK161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound…Engineered Tissue Solutions, LLC · 2016
- Descendant · cites it directly · 2 of its ownK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · 2 generations on · 1 of its ownK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- Descendant · 2 generations on · 0 of its ownK241660 SiOxD® Wound MatrixSioxmed, LLC · 2024
Show all 9 generations
- Root · 9 generations backK842066 Peri-Guard Pericardial PatchGenetic Laboratories, Inc. · 1985
- 8 generations backK961811 Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 7 generations backK983162 Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips…Bio-Vascular, Inc. · 1998 · Recalled
- 6 generations backK992537 Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry…Bio-Vascular, Inc. · 2000
- 5 generations backK014183 Afb (Absorbable Foam Buttress)J&J Corporate Biomaterials Center · 2002
- 4 generations backK030782 Seamguard Bioabsorbable Staple Line Reinforcement MaterialW. L. Gore & Associates, Inc. · 2003
- 3 generations backK033671 Gore Bioabsorbable MeshW. L. Gore & Associates, Inc. · 2003
- 2 generations backK083266 Gore Bio-a Fistula PlugW. L. Gore & Associates, Inc. · 2009
- 1 generation backK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- This deviceK161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound…Engineered Tissue Solutions, LLC · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K842066 | Peri-Guard Pericardial Patch | Genetic Laboratories, Inc. | 1985 | — |
| −8 | K961811 | Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −7 | K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve… | Bio-Vascular, Inc. | 1998 | 2 |
| −6 | K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated… | Bio-Vascular, Inc. | 2000 | — |
| −5 | K014183 | Afb (Absorbable Foam Buttress) | J&J Corporate Biomaterials Center | 2002 | — |
| −4 | K030782 | Seamguard Bioabsorbable Staple Line Reinforcement Material | W. L. Gore & Associates, Inc. | 2003 | — |
| −3 | K033671 | Gore Bioabsorbable Mesh | W. L. Gore & Associates, Inc. | 2003 | — |
| −2 | K083266 | Gore Bio-a Fistula Plug | W. L. Gore & Associates, Inc. | 2009 | — |
| −1 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| 0 (this device) | K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”… | Engineered Tissue Solutions, LLC | 2016 | — |
| +1 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +2 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
| +2 | K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 3 | 0 |
| 2001 | 8 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 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 QSZ? 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 QSZ device
- #1 K254256 LUOFUCON® Wound Matrixscore 14.6 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K071552 | Puracol Plus AG Collagen Microscaffold Wound DressingSummary page 5…Dressing, Wound, Drug) Device Class: Unclassified 4. Predicate Devices Medline Industries, Inc. Puracol® Plus Ag+ MicroScaffold™ Wound Dressing (K071552) W.L. Gore & Associates, Inc. GORE® BIO-A® Wound Matrix (K132397) 5. Intended Use / Indications for Use The Mirragen™… | 2008 |
| * | K132397 | Gore Bio-a Wound MatrixSummary page 5…redicate Devices Medline Industries, Inc. Puracol® Plus Ag+ MicroScaffold™ Wound Dressing (K071552) W.L. Gore & Associates, Inc. GORE® BIO-A® Wound Matrix (K132397) 5. Intended Use / Indications for Use The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds.… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222189 | SiOxD Wound Matrix | 2022 | 2 |
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 31 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 77 ancestors have a recall of any class.
- Of its descendants, K222189 (Sioxmed, LLC, 2022) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K071552.
How does its category compare?
All QSZ devicesQSZ Absorbable Synthetic Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · QSZ
4so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QSZ
85in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QSZ
No recall names QSZ since 2007.
Adverse event reports per year · QSZ
38in 2025
MAUDE reports naming product code QSZ, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 3 | 85 | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 15 |
| 2024 | 1 | — | 0 | 15 |
| 2025 | 2 | — | 0 | 38 |
| 2026 | 4 | 159 | 0 | — |
What is it indicated for?
The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include:
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, first and second degree burns, skin tears) and draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161067 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161067
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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