# K181300: Embosphere Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, S.A.
- Decided: Jul 16, 2018 after 60 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K961923 (1996). 7 ancestors in all.
9 later devices descend from it; 2 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 4.

## Most influential descendants
- K183120: EmboCube Embolization Gelatin (2019), 7 descendants of its own
- K213385: GEM (2022), 3 descendants of its own
- K242507: OBSIDIO™ Conformable Embolic (2024), 2 descendants of its own
- K240873: TEMBO Embolic System (2024), 1 descendant of its own
- K261488: OBSIDIO Conformable Embolic (2026), 0 descendants of its own

## Recalls of this device
- Aug 10, 2026 · Class II · Z-3305-2026: Microspheres used in embolization of tumors, prostatic arteries, arteriovenous malformations, and blood vessels may have holes in packaging that may affect the sterile barrier, which if used could lea

## 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/K181300
Methodology: https://510kreport.com/methodology