De Novo · Granted
GrantedComfort Marker 2.0.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Precision BV · QRN Radiation Therapy Marking Device
Granted on Dec 10, 2021 as a new device type through De Novo after a 536-day review. 1 later device descends from it.
- Decided
- Dec 10, 2021
- Review
- 536 days
- Class
- Class II
- Product code
- QRN
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN200041 Comfort Marker 2.0.Medical Precision BV · 2021
- Descendant · cites it directly · 0 of its ownK222112 Comfort Marker 2.0Medical Precision BV · 2023
Most influential descendants
Showing 1 of 1 · See all- K222112Comfort Marker 2.0Medical Precision BV · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200041 | Comfort Marker 2.0. | Medical Precision BV | 2021 | — |
| +1 | K222112 | Comfort Marker 2.0 | Medical Precision BV | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 QRN? 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 QRN device
- #1 K222112 Comfort Marker 2.0score 5.1 · 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 |
|---|---|---|---|
| K222112 | Comfort Marker 2.0 | 2023 | 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, K222112 (Medical Precision BV, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QRN devicesQRN Radiation Therapy Marking Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · QRN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QRN
Too few QRN 510(k)s in any year since 2007 to give a median.
Recalls per year · QRN
No recall names QRN since 2007.
Adverse event reports per year · QRN
No MAUDE report names QRN 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 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device is indicated for use for applying ink to the skin to identify the margins for radiation therapy. The device is intended to be used in clinical settings by Radiotherapy professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200041 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200041: Comfort Marker 2.0..” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200041
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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