# K052742: Hepasphere Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, Inc.
- Decided: Nov 7, 2006 after 403 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: 4 generations back to K010026 (2001). 11 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042231: Gelspheres Microspheres and Bead Block Compressible Microspheres, Biocompatibles UK Limited (2004) Summary page 1.
- K022427: Contour SE Microspheres, Boston Scientific Corp (2002) Summary page 1.
- K032542: Modification to Contour SE Microspheres, Boston Scientific Corp (2003) Summary page 1.
- K944354: Contour Emboli, Interventional Therapeutics Corp. (1994) Summary page 1.
- K991549: Embosphere Microspheres, Biosphere Medical (2000) Summary page 1.

## Most influential descendants
- K113266: Gel-Block Embolization Pledgets (2012), 8 descendants of its own
- K143038: Gel-Block 10X embolization pledgets (2014), 2 descendants of its own
- K133237: Gel-Bead Embolization Spheres (2014), 2 descendants of its own
- K181021: EmboCube Embolization Gelatin (2018), 1 descendant of its own
- K181051: IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm (2018), 1 descendant 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/K052742
Methodology: https://510kreport.com/methodology