# K250971: Embosphere Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, S.A.
- Decided: May 16, 2025 after 46 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: 5 generations back to K961923 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181300: Embosphere Microspheres, Biosphere Medical, S.A. (2018) Summary page 5.

## Indications for use
Embosphere Microspheres are indicated for use in the embolization of: -Hypervascular tumors, including symptomatic uterine fibroids -Prostatic arteries for symptomatic Benign Prostatic Hyperplasia (BPH) -Arteriovenous malformations -Blood vessels to occlude blood flow to control bleeding/hemorrhaging in the peripheral vasculature

Source page: https://510kreport.com/device/K250971
Methodology: https://510kreport.com/methodology