510(k) · Cleared
ClearedComfort 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
Cleared on Mar 30, 2023 as substantially equivalent to DEN200041 (Medical Precision BV, 2021) after a 255-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Mar 30, 2023
- Review
- 255 days
- Class
- Class II
- Product code
- QRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200041 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200041 Comfort Marker 2.0.Medical Precision BV · 2021
- This deviceK222112 Comfort Marker 2.0Medical Precision BV · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200041 | Comfort Marker 2.0. | Medical Precision BV | 2021 | — |
| 0 (this device) | K222112 | Comfort Marker 2.0 | Medical Precision BV | 2023 | — |
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 QRN? 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 |
|---|---|---|---|
| * | DEN200041 | Comfort Marker 2.0.Summary page 4…21 CRF 892.5785 Product Code QRN Legally Marketed Predicate Device Predicate Trade Name Comfort Marker 2.0 (DEN200041) Product Code QRN Device Description Summary Comfort Marker 2.0 is an application system for placing… | 2021 |
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 QRN devicesQRN Radiation Therapy Marking Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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/K222112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K222112: Comfort Marker 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K222112
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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