# K132675: Embozene Microspheres

- Pathway: 510(k) (Special)
- Applicant: Celonova Biosciences, Inc.
- Decided: Oct 3, 2013 after 36 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: 7 generations back to K961923 (1996). 16 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073417: Embozene Microspheres, Celonova Biosciences, Inc. (2008) Summary page 1.

## Most influential descendants
- K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres (2014), 2 descendants of its own
- K141209: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres (2014), 1 descendant of its own
- K242794: ONCOZENE Microspheres (2024), 0 descendants of its own
- K162373: LC Bead LUMI (2016), 0 descendants of its own

## Indications for use
Embozene4D Microspheres are Indicated for the embolization of hypervascular tumors and arterlovenous malformations.

Source page: https://510kreport.com/device/K132675
Methodology: https://510kreport.com/methodology