510(k) · Cleared
ClearedNovoSorb® MTX
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 Mar 5, 2025 as substantially equivalent to K221686 (Polynovo Biomaterials Pty, Ltd., 2022) after a 225-day review. Its family tree reaches back 1 generation to 2022. 1 later device descends from it.
- Decided
- Mar 5, 2025
- Review
- 225 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K221686 (2022). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K251567NovoSorb BTMPolynovo Biomaterials Pty, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K221686 | NovoSorb Matrix | Polynovo Biomaterials Pty, Ltd. | 2022 | — |
| 0 (this device) | K242149 | NovoSorb® MTX | Polynovo Biomaterials Pty, Ltd. | 2025 | — |
| +1 | K251567 | NovoSorb BTM | Polynovo Biomaterials Pty, Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251567 | NovoSorb BTM | 2025 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K251567 (Polynovo Biomaterials Pty, Ltd., 2025) has gone furthest, with 0 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. 2025, 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?
NovoSorb® MTX is indicated for the management of wounds including: partial and full thickness
wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, tunneled/
undermined wounds, 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 single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242149 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242149: NovoSorb® MTX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242149
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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