# K130537: Biopsy Sciences LLC Hydromark Breast Biopsy Site Marker

- Pathway: 510(k) (Special)
- Applicant: Biopsy Sciences, LLC
- Decided: Mar 29, 2013 after 28 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: 7 generations back to K023694 (2003). 9 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K060769: Hydromark Biopsy Site Marker, Biopsy Sciences, LLC (2006) Summary page 1.
- K083006: Biopsy Sciences, Inc., Hydromark Breast Biopsy Site Marker, Biopsy Sciences, LLC (2009) Summary page 1.
- K090501: Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1, Biopsy Sciences, LLC (2009) Summary page 1.
- K121113: Biopsy Sciences, Inc. Hydromark Brest Biosy Site Marker, Biopsy Sciences, LLC (2012) Summary page 1.

## Most influential descendants
- K161021: HydroMARK Breast Biopsy Site Marker (2016), 2 descendants of its own
- 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
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/K130537
Methodology: https://510kreport.com/methodology