# K113822: Quadrasphere 30 to 60

- Pathway: 510(k) (Special)
- Applicant: Biosphere Medical, Inc.
- Decided: Mar 8, 2012 after 72 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K010026 (2001). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 1.

## Most influential descendants
- K151187: QuadraSphere Microspheres (2015), 0 descendants of its own

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

Source page: https://510kreport.com/device/K113822
Methodology: https://510kreport.com/methodology