# K151187: QuadraSphere Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, S.A.
- Decided: Jul 27, 2015 after 84 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). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052742: Hepasphere Microspheres, Biosphere Medical, Inc. (2006) Summary page 4.
- K113822: Quadrasphere 30 to 60, Biosphere Medical, Inc. (2012) Summary page 4.

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

Source page: https://510kreport.com/device/K151187
Methodology: https://510kreport.com/methodology