# K172372: QuadraSphere Microspheres

- Pathway: 510(k) (Special)
- Applicant: Biosphere Medical, S.A.
- Decided: Sep 6, 2017 after 30 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: 1 generation back to K153102 (2015). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153102: QuadraSphere Microspheres, Biosphere Medical, S.A. (2015) Summary page 4.

## Most influential descendants
- K231554: UniPearls® Embolic Microspheres (2023), 1 descendant of its own
- K252812: UniPearls® Embolic Microspheres (2026), 0 descendants of its own

## Indications for use
QuadraSphere Microspheres are indicated for embolization of hypervascularized tumors including hepatoma, and peripheral arteriovenous malformations.

Source page: https://510kreport.com/device/K172372
Methodology: https://510kreport.com/methodology