510(k) · Cleared
ClearedSupraSDRM Biodegradable Matrix Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polymedics Innovations, GmbH · QSZ Absorbable Synthetic Wound Dressing
Cleared on Jun 28, 2017 as substantially equivalent to K090160 (Polymedics Innovations, GmbH, 2009) after a 155-day review. Its family tree reaches back 6 generations to 1997.
- Decided
- Jun 28, 2017
- Review
- 155 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K973688 (1997). 29 ancestors in all, the oldest K894541 (1989). No later device cites it as a predicate yet.
- Root · 6 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 5 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 4 generations backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- 3 generations backK040019 SilversealNoble Fiber Technologies · 2004
- 2 generations backK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- 1 generation backK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
- This deviceK170213 SupraSDRM Biodegradable Matrix Wound DressingPolymedics Innovations, GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −5 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −4 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| −3 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −2 | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| −1 | K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations, GmbH | 2009 | — |
| 0 (this device) | K170213 | SupraSDRM Biodegradable Matrix Wound Dressing | Polymedics Innovations, GmbH | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (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 |
|---|---|---|---|
| * | K090160 | Suprathel Wound and Burn DressingSummary page 7…wing predicate device and reference devices which have been determined by FDA to be substantially equivalent to pre-amendment devices: Suprathel Wound and Burn Dressing (K090160) predicate device and the Integra LifeSciences Bilayer Matrix Wound Dressing (K021792) reference device, and Progressive Woundcar… | 2009 |
| † | K021792 | Bilayer Matrix Wound Dressing | 2002 |
| † | K122634 | Iodofoam Iodophor Foam Dressing | 2013 |
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 20 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 29 ancestors has a recall.
- 3 other devices also cite its predicate K090160.
How does its category compare?
All QSZ devicesQSZ Absorbable Synthetic Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 SupraSDRM Biodegradable Matrix Wound Dressing is indicated for use in the management of:
• Partial and full thickness wounds
• Pressure (stage I and IV) and venous ulcers
• Ulcers caused by mixed vascular etiologies
• Venous stasis and diabetic ulcers
• 1st and 2nd degree burns
• Partial thickness burns
• Cuts and abrasions
• Acute wounds
• Trauma wounds
• Surgical wounds
• Superficial wounds
• Grafted wounds and donor sites
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170213 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170213: SupraSDRM Biodegradable Matrix Wound Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170213
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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