# K153102: QuadraSphere Microspheres

- Pathway: 510(k) (Special)
- Applicant: Biosphere Medical, S.A.
- Decided: Nov 23, 2015 after 28 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
No predicates in its family tree.
3 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K172372: QuadraSphere Microspheres (2017), 2 descendants of its own
- K231554: UniPearls® Embolic Microspheres (2023), 1 descendant of its own
- K252812: UniPearls® Embolic Microspheres (2026), 0 descendants of its own

Source page: https://510kreport.com/device/K153102
Methodology: https://510kreport.com/methodology