# K222112: Comfort Marker 2.0

- Pathway: 510(k) (Traditional)
- Applicant: Medical Precision BV
- Decided: Mar 30, 2023 after 255 days
- Product code: QRN (Radiation Therapy Marking Device)
- Device class: 2
- Regulation: 21 CFR 892.5785
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN200041 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200041: Comfort Marker 2.0., Medical Precision BV (2021) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K222112
Methodology: https://510kreport.com/methodology