# K161021: HydroMARK Breast Biopsy Site Marker

- Pathway: 510(k) (Special)
- Applicant: Devicor Medical Products, Inc.
- Decided: May 5, 2016 after 23 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: 8 generations back to K023694 (2003). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121113: Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker, Biopsy Sciences, LLC (2012) Summary page 4.
- K130537: Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker, Biopsy Sciences, LLC (2013) Summary page 4.

## Most influential descendants
- K203097: HydroMARK Breast Biopsy Site Markers (2020), 0 descendants of its own
- K170803: HydroMARK Breast Biopsy Site Markers (2017), 0 descendants of its own

## 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/K161021
Methodology: https://510kreport.com/methodology