De Novo · Granted
GrantedOxiplex®
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fziomed, Inc. · QVL Absorbable Gel For Intraoperative Use In Spine Surgery
Granted on Jun 17, 2025 as a new device type through De Novo after a 330-day review. 1 later device descends from it.
- Decided
- Jun 17, 2025
- Review
- 330 days
- Class
- Class II
- Product code
- QVL
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN240038 Oxiplex®Fziomed, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK253326 OxiplexFziomed, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K253326OxiplexFziomed, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN240038 | Oxiplex® | Fziomed, Inc. | 2025 | — |
| +1 | K253326 | Oxiplex | Fziomed, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA De Novo 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 QVL? 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 QVL device
- #1 K253326 Oxiplexscore 11.3 · 1 generation · no Class I recall
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K253326 | Oxiplex | 2026 | 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?
- Of its descendants, K253326 (Fziomed, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QVL devicesQVL Absorbable Gel For Intraoperative Use In Spine Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QVL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QVL
Too few QVL 510(k)s in any year since 2007 to give a median.
Recalls per year · QVL
No recall names QVL since 2007.
Adverse event reports per year · QVL
No MAUDE report names QVL since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Oxiplex® is a synthetic, absorbable gel intended as an adjunct to lumbar spinal surgery in adult patients with leg pain, back pain, and neurological symptoms undergoing discectomy to reduce leg pain and neurological symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240038 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240038: Oxiplex®.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240038
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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