510(k) · Cleared
ClearedBTM Wound Dressing
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Polynovo Biomaterials Pty, Ltd. · QSZ Absorbable Synthetic Wound Dressing
Cleared on Dec 23, 2015 as substantially equivalent to K090160 (Polymedics Innovations, GmbH, 2009) and 1 other predicate after a 447-day review. Its family tree reaches back 6 generations to 1997. 5 later devices descend from it.
- Decided
- Dec 23, 2015
- Review
- 447 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K973688 (1997). 41 ancestors in all, the oldest K881854 (1988). 5 later devices descend from it, 1 citing it directly.
- 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 deviceK142879 BTM Wound DressingPolynovo Biomaterials Pty, Ltd. · 2015
- Descendant · cites it directly · 4 of its ownK172140 NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing…Polynovo Biomaterials Pty, Ltd. · 2017
- Descendant · 2 generations on · 2 of its ownK231937 Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK240298 Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK251567 NovoSorb BTMPolynovo Biomaterials Pty, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK243181 Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K172140NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)…Polynovo Biomaterials Pty, Ltd. · 2017 · cites it directly4descendants
- K231937Foundation Dermal Regeneration Scaffold (DRS) SoloBionova Medical, Inc. · 2023 · 2 generations on2descendants
- K240298Foundation Dermal Regeneration Scaffold Plus (DRS+) DuoBionova Medical, Inc. · 2024 · 3 generations on1descendant
- K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd. · 2025 · 2 generations on0descendants
- K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) SoloBionova Medical, Inc. · 2024 · 3 generations on0descendants
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) | K142879 | BTM Wound Dressing | Polynovo Biomaterials Pty, Ltd. | 2015 | — |
| +1 | K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x… | Polynovo Biomaterials Pty, Ltd. | 2017 | — |
| +2 | K231937 | Foundation Dermal Regeneration Scaffold (DRS) Solo | Bionova Medical, Inc. | 2023 | — |
| +3 | K240298 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo | Bionova Medical, Inc. | 2024 | — |
| +2 | K251567 | NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. | 2025 | — |
| +3 | K243181 | Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo | Bionova Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K090160 | Suprathel Wound and Burn DressingSummary page 5…General & Plastic Surgery Product Code: FRO Predicate Devices: Suprathel Wound and Burn Dressing (K090160) Bilayer Matrix Wound Dressing (K021792) Indications for Use: The BTM Wound dressing is in… | 2009 |
| * | K021792 | Bilayer Matrix Wound DressingSummary page 5…FRO Predicate Devices: Suprathel Wound and Burn Dressing (K090160) Bilayer Matrix Wound Dressing (K021792) Indications for Use: The BTM Wound dressing is indicated for the management of wounds including: partial and full thickness wo… | 2002 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172140 | NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm)… | 2017 | 4 |
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 18 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 41 ancestors has a recall of any class.
- Of its descendants, K172140 (Polynovo Biomaterials Pty, Ltd., 2017) has gone furthest, with 4 descendants of its own.
- 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. 2015, 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 BTM Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device is intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142879: BTM 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/K142879
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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