# K013069: Biospeed

- Pathway: 510(k) (Traditional)
- Applicant: H.S. Hospital Services S.P.A.
- Decided: Dec 12, 2001 after 90 days
- Product code: FCG (Biopsy Needle)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951598 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951598: Pro-B Biopsy Needle, Promedical, Ltd. (1995) Summary page 1.

## Indications for use
This device is an automated, disposable biopsy needle and can be used in Fluoroscopic, CT and Mammographic procedures to obtain biopsies of various tissues including those from Prostate Kidney, Breast and Liver.

Source page: https://510kreport.com/device/K013069
Methodology: https://510kreport.com/methodology