# K162373: LC Bead LUMI

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles UK Limited
- Decided: Dec 16, 2016 after 114 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: 8 generations back to K961923 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152157: LC Bead LUMI, Biocompatibles UK, Ltd. (2015) Summary page 4.
- K132675: Embozene Microspheres, Celonova Biosciences, Inc. (2013) Summary page 4.

## Indications for use
LC Bead LUMI is intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).

Source page: https://510kreport.com/device/K162373
Methodology: https://510kreport.com/methodology