510(k) · Cleared
ClearedSiOxD Wound Matrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sioxmed, LLC · QSZ Absorbable Synthetic Wound Dressing
Cleared on Nov 18, 2022 as substantially equivalent to K161067 (Engineered Tissue Solutions, LLC, 2016) and 1 other predicate after a 119-day review. Its family tree reaches back 10 generations to 1995. 2 later devices descend from it.
- Decided
- Nov 18, 2022
- Review
- 119 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K953781 (1995). 124 ancestors in all, the oldest K810428 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 6 generations between
- 3 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 2 generations backK072890 Stasilon FREntegrion, Inc. · 2007
- 1 generation backK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- This deviceK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- Descendant · cites it directly · 1 of its ownK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- Descendant · cites it directly · 0 of its ownK241660 SiOxD® Wound MatrixSioxmed, LLC · 2024
Show all 10 generations
- Root · 10 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 9 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 8 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 7 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 6 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 5 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 4 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 3 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 2 generations backK072890 Stasilon FREntegrion, Inc. · 2007
- 1 generation backK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- This deviceK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
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 |
|---|---|---|---|---|---|
| −10 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −9 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −8 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −7 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −6 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −5 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −4 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −3 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| −2 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| −1 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
| 0 (this device) | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| +1 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
| +1 | K241660 | SiOxD® Wound Matrix | Sioxmed, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 3 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 9 | 0 |
| 1997 | 8 | 0 |
| 1998 | 14 | 0 |
| 1999 | 6 | 0 |
| 2000 | 7 | 0 |
| 2001 | 8 | 0 |
| 2002 | 11 | 0 |
| 2003 | 8 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Summary page 4…D Wound Matrix Common Name Wound Dressing FRO Code –Classification Unclassified: Class II K161067 Engineered Tissue Solutions, LLC Mirragen™ Advanced Wound Primary Predicate Matrix Additional Predicate… | 2016 |
| * | K142363 | Nustat, Nustat XRSummary page 4…K161067 Engineered Tissue Solutions, LLC Mirragen™ Advanced Wound Primary Predicate Matrix Additional Predicate K142363 Beeken Biomedical NuStat HemoStatic Dressing Device Device Description The SiOxD Wound Matrix is a non-pyrogenic, sterile, sing… | 2015 |
What descends from it? (2)
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 27 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 7 of the 124 ancestors have a recall of any class.
- Of its descendants, K232847 (Sioxmed, LLC, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All QSZ devicesQSZ Absorbable Synthetic Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 SiOxD 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 degree and partial thickness burns, skin tears) and draining wounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222189 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222189: SiOxD Wound Matrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222189
Report an extraction error
Are you the manufacturer?
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