510(k) · Cleared
ClearedOxiplex
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
Cleared on May 1, 2026 as substantially equivalent to DEN240038 (Fziomed, Inc., 2025) after a 213-day review. Its family tree reaches back 1 generation to 2025.
- Decided
- May 1, 2026
- Review
- 213 days
- Class
- Class II
- Product code
- QVL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN240038 (2025). No later device cites it as a predicate yet.
- Root · 1 generation backDEN240038 Oxiplex®Fziomed, Inc. · 2025
- This deviceK253326 OxiplexFziomed, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN240038 | Oxiplex® | Fziomed, Inc. | 2025 | — |
| 0 (this device) | K253326 | Oxiplex | Fziomed, Inc. | 2026 | — |
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 QVL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | DEN240038 | Oxiplex®Summary page 5…egulation: 21 CFR §888.3047 Regulatory Classification: 2 Product Code: QVL Predicate Devices: Primary: Oxiplex® (DEN240038) Device Description: Oxiplex® is a synthetic, absorbable, clear, flowable, viscoelastic gel that is comprised of sodium carbox… | 2025 |
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?
- Its one ancestor has no recall.
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. 2026, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253326: Oxiplex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253326
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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