510(k) · Cleared
ClearedHyalomatrix
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Anika Therapeutics, Inc. · QSZ Absorbable Synthetic Wound Dressing
Cleared on Sep 2, 2026 as substantially equivalent to K073251 (Fidia Advanced Biopolymers Srl, 2007) after a 134-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Sep 2, 2026
- Review
- 134 days
- Class
- Class U
- Product code
- QSZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K881854 (1988). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK881854 Sorbsan Topical Wound DressingE.G. Dick & Assoc. · 1988
- 4 generations backK982597 Fibrcol Plus Collagen Wound Dressing with AlginateJohnson & Johnson Medical, Inc. · 1998
- 3 generations backK993948 Sis Wound Dressing IICook Biotech, Inc. · 2000
- 2 generations backK021792 Bilayer Matrix Wound DressingIntegra Lifesciences Corp. · 2002 · Recalled
- 1 generation backK073251 Hyalomatrix PAFidia Advanced Biopolymers Srl · 2007 · Recalled
- This deviceK261311 HyalomatrixAnika Therapeutics, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K881854 | Sorbsan Topical Wound Dressing | E.G. Dick & Assoc. | 1988 | — |
| −4 | K982597 | Fibrcol Plus Collagen Wound Dressing with Alginate | Johnson & Johnson Medical, Inc. | 1998 | — |
| −3 | K993948 | Sis Wound Dressing II | Cook Biotech, Inc. | 2000 | — |
| −2 | K021792 | Bilayer Matrix Wound Dressing | Integra Lifesciences Corp. | 2002 | 1 |
| −1 | K073251 | Hyalomatrix PA | Fidia Advanced Biopolymers Srl | 2007 | 1 |
| 0 (this device) | K261311 | Hyalomatrix | Anika Therapeutics, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 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 |
|---|---|---|---|
| * | K073251 | Hyalomatrix PASummary page 5…Not applicable Regulation Name: Not applicable Product Code: QSZ Predicate Device Information: HYALOMATRIX – K073251 – cleared on December 14, 2007 Reason for 510(k) submission The purpose of this submission it the update of the packaging config… | 2007 |
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 38 years and passes through 6 companies; a new generation was cleared every 5.3 years on median.
- 2 of the 15 ancestors have a recall of any class.
- 1 other device also cites its predicate K073251.
How does its category compare?
All QSZ devicesQSZ Absorbable Synthetic Wound Dressing: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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?
HYALOMATRIX is indicated for the management of wounds including:
•Partial and full-thickness wounds
•Partial thickness second-degree burns
•Pressure ulcers
•Venous ulcers
•Diabetic ulcers
•Chronic vascular ulcers
•Tunneled/undetermined wounds
•Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence)
•Trauma wounds (abrasions, lacerations, skin tears)
•Draining wounds
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261311 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261311: Hyalomatrix.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261311
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026