# K183120: EmboCube Embolization Gelatin

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, S.A.
- Decided: Aug 6, 2019 after 270 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.
7 later devices descend from it; 3 cite it directly.
1 of 16 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181300: Embosphere Microspheres, Biosphere Medical, S.A. (2018) Summary page 4.

## Most influential descendants
- 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
- K253677: Tembo Embolic System (2025), 0 descendants of its own

## Indications for use
EmboCube Embolization Gelatin is indicated for use in embolization of: - Hypervascular tumors - Blood vessels to occlude blood flow to control bleeding / hemorrhaging in the peripheral vasculature

Source page: https://510kreport.com/device/K183120
Methodology: https://510kreport.com/methodology