510(k) · Cleared
ClearedSuprathel Wound and Burn 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 May 20, 2009 as substantially equivalent to K012995 (Biocore Medical Technologies, Inc., 2001) and 7 other predicates after a 118-day review. Its family tree reaches back 5 generations to 1997. 18 later devices descend from it.
- Decided
- May 20, 2009
- Review
- 118 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 5 generations to K973688 (1997). 28 ancestors in all, the oldest K894541 (1989). 18 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK973688 Duoderm Control Gel Formula Border DressingConvatec, Ltd. · 1997
- 4 generations backK983362 NU-Gel * Wound DressingJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK022995 Collatek HydrogelBiocore Medical Technologies, Inc. · 2002
- 2 generations backK040019 SilversealNoble Fiber Technologies · 2004
- 1 generation backK061227 Hydrolyzed Collagen/AG Wound Gel with SilverThe Hymed Group Corp. · 2006
- This deviceK090160 Suprathel Wound and Burn DressingPolymedics Innovations, GmbH · 2009
- Descendant · cites it directly · 10 of its ownK132397 Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014
- Descendant · cites it directly · 5 of its ownK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- Descendant · 2 generations on · 4 of its ownK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- Descendant · 2 generations on · 4 of its ownK170300 Restrata Wound MatrixAcera Surgical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK161067 Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound…Engineered Tissue Solutions, LLC · 2016
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K132397Gore Bio-a Wound MatrixW. L. Gore & Associates, Inc. · 2014 · cites it directly10descendants
- K142879BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015 · cites it directly5descendants
- K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd. · 2017 · 2 generations on4descendants
- K170300Restrata Wound MatrixAcera Surgical, Inc. · 2017 · 2 generations on4descendants
- K161067Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen…Engineered Tissue Solutions, LLC · 2016 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973688 | Duoderm Control Gel Formula Border Dressing | Convatec, Ltd. | 1997 | — |
| −4 | K983362 | NU-Gel * Wound Dressing | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K022995 | Collatek Hydrogel | Biocore Medical Technologies, Inc. | 2002 | — |
| −2 | K040019 | Silverseal | Noble Fiber Technologies | 2004 | — |
| −1 | K061227 | Hydrolyzed Collagen/AG Wound Gel with Silver | The Hymed Group Corp. | 2006 | — |
| 0 (this device) | K090160 | Suprathel Wound and Burn Dressing | Polymedics Innovations, GmbH | 2009 | — |
| +1 | K132397 | Gore Bio-a Wound Matrix | W. L. Gore & Associates, Inc. | 2014 | — |
| +1 | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| +2 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x… | Polynovo Biomaterials Pty, Ltd. | 2017 | — |
| +2 | K170300 | Restrata Wound Matrix | Acera Surgical, Inc. | 2017 | 1 |
| +2 | K161067 | Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”… | Engineered Tissue Solutions, LLC | 2016 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (8)
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 |
|---|---|---|---|
| * | K012995 | Collatek SheetSummary page 7…with the following predicate devices which have been determined by-FDA to be substantially equivalent to pre-amendment devices: BioCore Medical Collatek Sheet (K012995), Biomet Merck Topkin Foil (K031684), Inion OTPS Biodegradable Pin (K031712), MacroPore Surgi-Wrap MAST Bioresorbable Sheet… | 2001 |
| * | K031684 | Topkin Wound DressingSummary page 7…which have been determined by-FDA to be substantially equivalent to pre-amendment devices: BioCore Medical Collatek Sheet (K012995), Biomet Merck Topkin Foil (K031684), Inion OTPS Biodegradable Pin (K031712), MacroPore Surgi-Wrap MAST Bioresorbable Sheet (K031955), Nymed Group Hydrolyz… | 2003 |
| * | K031712 | Inion Otps Biodegradable PinSummary page 7…substantially equivalent to pre-amendment devices: BioCore Medical Collatek Sheet (K012995), Biomet Merck Topkin Foil (K031684), Inion OTPS Biodegradable Pin (K031712), MacroPore Surgi-Wrap MAST Bioresorbable Sheet (K031955), Nymed Group Hydrolyzed Collagen Gel with Silver (K061227), Biomet… | 2003 |
| * | K031955 | Macropore Surgi-Wrap Mast Bioresorbable SheetSummary page 7…Medical Collatek Sheet (K012995), Biomet Merck Topkin Foil (K031684), Inion OTPS Biodegradable Pin (K031712), MacroPore Surgi-Wrap MAST Bioresorbable Sheet (K031955), Nymed Group Hydrolyzed Collagen Gel with Silver (K061227), Biomet Mesofol (K062558), BioDerm BTF Thin Film Wound Dressing… | 2003 |
| * | K061227 | Hydrolyzed Collagen/AG Wound Gel with SilverSummary page 7…il (K031684), Inion OTPS Biodegradable Pin (K031712), MacroPore Surgi-Wrap MAST Bioresorbable Sheet (K031955), Nymed Group Hydrolyzed Collagen Gel with Silver (K061227), Biomet Mesofol (K062558), BioDerm BTF Thin Film Wound Dressing (K982939), and Integra Life Sciences HeliDerm (K990086… | 2006 |
| * | K062558 | Mesosfol Surgical FilmSummary page 7…iodegradable Pin (K031712), MacroPore Surgi-Wrap MAST Bioresorbable Sheet (K031955), Nymed Group Hydrolyzed Collagen Gel with Silver (K061227), Biomet Mesofol (K062558), BioDerm BTF Thin Film Wound Dressing (K982939), and Integra Life Sciences HeliDerm (K990086); Class II medical devices tha… | 2007 |
| * | K982939 | BTF Thin Film Wound DressingSummary page 7…MAST Bioresorbable Sheet (K031955), Nymed Group Hydrolyzed Collagen Gel with Silver (K061227), Biomet Mesofol (K062558), BioDerm BTF Thin Film Wound Dressing (K982939), and Integra Life Sciences HeliDerm (K990086); Class II medical devices that were cleared for marketing in the United… | 1998 |
| * | K990086 | Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 GramSummary page 7…up Hydrolyzed Collagen Gel with Silver (K061227), Biomet Mesofol (K062558), BioDerm BTF Thin Film Wound Dressing (K982939), and Integra Life Sciences HeliDerm (K990086); Class II medical devices that were cleared for marketing in the United States under K012995, K031684, K031712, K031955,… | 1999 |
What descends from it? (18)
See all 184 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 12 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 28 ancestors has a recall.
- Of its descendants, K132397 (W. L. Gore & Associates, Inc., 2014) has gone furthest, with 10 descendants 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. 2009, 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 'Suprathel Wound and Burn Dressing is indicated for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions. The dressing is intended to maintain a moist wound healing environment. A moist wound healing environment allows autolytic debridement. The Suprathel Wound and Burn Dressing is used in the management of: * Partial and full thickness wounds * Pressure (stage I and IV) and venous ulcers * Ulcers…
Read the full statement (113 words)
The 'Suprathel Wound and Burn Dressing is indicated for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions. The dressing is intended to maintain a moist wound healing environment. A moist wound healing environment allows autolytic debridement.
The Suprathel Wound and Burn Dressing is used 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/K090160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090160: Suprathel Wound and Burn Dressing.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090160
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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