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 Jul 5, 2024 as substantially equivalent to K222189 (Sioxmed, LLC, 2022) and 1 other predicate after a 25-day review. Its family tree reaches back 12 generations to 1995.
- Decided
- Jul 5, 2024
- Review
- 25 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K953781 (1995). 126 ancestors in all, the oldest K810428 (1981). No later device cites it as a predicate yet.
- Root · 12 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 8 generations between
- 3 generations backK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- 2 generations backK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- 1 generation backK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- This deviceK241660 SiOxD® Wound MatrixSioxmed, LLC · 2024
Show all 12 generations
- Root · 12 generations backK953781 Innovative Technologies Calcium Alginate Wound DressingsInnovative Technologies, Ltd. · 1995
- 11 generations backK980989 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate DressingInnovative Technologies, Ltd. · 1998
- 10 generations backK010933 Seal-on Topical Hempstatic Powder SprayAlltracel Pharma, Ltd. · 2002
- 9 generations backK024107 Femostop Femoral Compression SystemRadi Medical Systems AB · 2002
- 8 generations backK040730 Vascular Solutions D-Stat Clamp Hemostatic ClampVascular Solutions, Inc. · 2004
- 7 generations backK050146 Vascular Solutions D-Stat Clamp AccessoryVascular Solutions, Inc. · 2005
- 6 generations backK053300 SyvekexcelMarine Polymer Technologies, Inc. · 2006
- 5 generations backK061219 D-Stat Dry Hemostatic BandageVascular Solutions, Inc. · 2006
- 4 generations backK072890 Stasilon FREntegrion, Inc. · 2007
- 3 generations backK142363 Nustat, Nustat XRBeeken Biomedical · 2015
- 2 generations backK222189 SiOxD Wound MatrixSioxmed, LLC · 2022
- 1 generation backK232847 SiOxD Wound MatrixSioxmed, LLC · 2023
- This deviceK241660 SiOxD® Wound MatrixSioxmed, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K953781 | Innovative Technologies Calcium Alginate Wound Dressings | Innovative Technologies, Ltd. | 1995 | — |
| −11 | K980989 | 3M Tegagen HI Alginate Dressing & 3M Tegagen HG Alginate Dressing | Innovative Technologies, Ltd. | 1998 | — |
| −10 | K010933 | Seal-on Topical Hempstatic Powder Spray | Alltracel Pharma, Ltd. | 2002 | — |
| −9 | K024107 | Femostop Femoral Compression System | Radi Medical Systems AB | 2002 | — |
| −8 | K040730 | Vascular Solutions D-Stat Clamp Hemostatic Clamp | Vascular Solutions, Inc. | 2004 | — |
| −7 | K050146 | Vascular Solutions D-Stat Clamp Accessory | Vascular Solutions, Inc. | 2005 | — |
| −6 | K053300 | Syvekexcel | Marine Polymer Technologies, Inc. | 2006 | — |
| −5 | K061219 | D-Stat Dry Hemostatic Bandage | Vascular Solutions, Inc. | 2006 | — |
| −4 | K072890 | Stasilon FR | Entegrion, Inc. | 2007 | — |
| −3 | K142363 | Nustat, Nustat XR | Beeken Biomedical | 2015 | — |
| −2 | K222189 | SiOxD Wound Matrix | Sioxmed, LLC | 2022 | — |
| −1 | K232847 | SiOxD Wound Matrix | Sioxmed, LLC | 2023 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K222189 | SiOxD Wound MatrixSummary page 5…eBME.com Trade Name SiOxD Wound Matrix Common Name Wound Dressing Code – FRO Classification Unclassified Predicate Device K222189, K232847 SiOxMed LLC SiOxD Wound Matrix Device Description The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use devi… | 2022 |
| * | K232847 | SiOxD Wound MatrixSummary page 5…Trade Name SiOxD Wound Matrix Common Name Wound Dressing Code – FRO Classification Unclassified Predicate Device K222189, K232847 SiOxMed LLC SiOxD Wound Matrix Device Description The SiOxD Wound Matrix is a non-pyrogenic, sterile, single use device… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 126 ancestors have a recall of any class.
- 1 other device also cites its predicate K222189.
How does its category compare?
All QSZ devicesQSZ Absorbable Synthetic Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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/K241660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241660: 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/K241660
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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