# K150876: Bead Block

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles UK, Ltd.
- Decided: Mar 7, 2016 after 341 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- 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 K961923 (1996). 7 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K173871: CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres (2018), 3 descendants of its own
- K250209: Polyvinyl Alcohol Embolic Microspheres (2025), 0 descendants of its own
- K232934: Sunsphere (2024), 0 descendants of its own
- K210562: HRSpheres Narrow-Size Embolic Microspheres (2021), 0 descendants of its own

## Indications for use
Bead Block™ microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).

Source page: https://510kreport.com/device/K150876
Methodology: https://510kreport.com/methodology