# K163388: XPress BCD Breast Compression Device

- Pathway: 510(k) (Traditional)
- Applicant: Xpress Bcd, LLC
- Decided: Jul 19, 2017 after 229 days
- Product code: POY (Post Breast Biopsy Hemostatic Breast Compression Device)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K923061 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113607: Biopsy Digit S Biopsy SL, Giotto USA, LLC (2012) Summary page 4.

## Indications for use
The Xpress BCD is a reusable device indicated for use with stereotactic biopsy platforms to apply temporary focal mechanical compression to a stereotactic breast biopsy site to achieve hemostasis.

Source page: https://510kreport.com/device/K163388
Methodology: https://510kreport.com/methodology