De Novo · Granted
GrantedBioXmark
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nanovi A/S · QUV Phase-Changing Fiducial Marker For Radiation Therapy
Granted on Dec 23, 2022 as a new device type through De Novo after a 294-day review.
- Decided
- Dec 23, 2022
- Review
- 294 days
- Class
- Class II
- Product code
- QUV
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
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 QUV? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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.
How does its category compare?
All QUV devicesQUV Phase-Changing Fiducial Marker For Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · QUV
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · QUV
Too few QUV 510(k)s in any year since 2007 to give a median.
Recalls per year · QUV
No recall names QUV since 2007.
Adverse event reports per year · QUV
No MAUDE report names QUV 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 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
BioXmark is indicated for use to radiographically mark lung, bladder and lymph nodes in adult patients for whom it has been determined that radiographical marking of tissue for radiation treatment is indicated for their cancer treatment.
BioXmark is implanted via image guided injection into tissue relevant for radiotherapy planning at a healthcare facility. BioXmark can be implanted in the tumor, lymph nodes or tissue adjacent to the tumor subject to irradiation or healthy tissue which should not be irradiated.
BioXmark is intended to mark tissue for at least 3 months after implantation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220017 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN220017: BioXmark.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN220017
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026