# DEN200041: Comfort Marker 2.0.

- Pathway: De Novo (Direct)
- Applicant: Medical Precision BV
- Decided: Dec 10, 2021 after 536 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K222112: Comfort Marker 2.0 (2023), 0 descendants of its own

## 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/DEN200041
Methodology: https://510kreport.com/methodology