# K203097: HydroMARK Breast Biopsy Site Markers

- Pathway: 510(k) (Traditional)
- Applicant: Devicor Medical Products, Inc.
- Decided: Dec 16, 2020 after 63 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K023694 (2003). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161021: HydroMARK Breast Biopsy Site Marker, Devicor Medical Products, Inc. (2016) Summary page 4.

## Indications for use
The HydroMARK® Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

Source page: https://510kreport.com/device/K203097
Methodology: https://510kreport.com/methodology