# K221961: HydroMARK Plus Breast Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: Devicor Medical Products, Inc.
- Decided: Jul 13, 2023 after 373 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.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212158: HydroMARK Breast Biopsy Site Marker, Devicor Medical Products, Inc. (2022) Summary page 6.

## Most influential descendants
- K253761: HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (2026), 0 descendants of its own
- K240527: HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) (2024), 0 descendants of its own

## Indications for use
HydroMARK™ Plus Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI

Source page: https://510kreport.com/device/K221961
Methodology: https://510kreport.com/methodology