# K212158: HydroMARK Breast Biopsy Site Marker

- Pathway: 510(k) (Traditional)
- Applicant: Devicor Medical Products, Inc.
- Decided: Apr 21, 2022 after 283 days
- Product code: NEU (Marker, Radiographic, Implantable)
- Device class: 2
- Regulation: 21 CFR 878.4300
- Recalls of this device: 1 (0 Class I)
- 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.
4 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210752: HydroMARK Breast Biopsy Site Marker, Devicor Medical Products, Inc. (2021) Summary page 5.

## Most influential descendants
- K221961: HydroMARK Plus Breast Biopsy Site Marker (2023), 2 descendants of its own
- 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
- K232615: LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) (2024), 0 descendants of its own

## Recalls of this device
- Apr 24, 2026 · Class II · Z-2239-2026: Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages labeled as T4 Markers.

## Indications for use
The HydroMARK 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/K212158
Methodology: https://510kreport.com/methodology