# K133237: Gel-Bead Embolization Spheres

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Apr 25, 2014 after 186 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: 6 generations back to K010026 (2001). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 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 1.
- K113266: Gel-Block Embolization Pledgets, Vascular Solutions, Inc. (2012) Summary page 1.

## Most influential descendants
- K171946: Gel-Bead (2017), 1 descendant of its own
- K173891: Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume (2018), 0 descendants of its own

## Indications for use
Gel-Bead embolization spheres is intended for use in embolization of hypervascular tumors.

Source page: https://510kreport.com/device/K133237
Methodology: https://510kreport.com/methodology