# K181021: EmboCube Embolization Gelatin

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, S.A.
- Decided: Sep 27, 2018 after 163 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: 7 generations back to K010026 (2001). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143038: Gel-Block 10X embolization pledgets, Vascular Solutions, Inc. (2014) Summary page 4.

## Most influential descendants
- K183578: Torpedo Gelatin Foam (2019), 0 descendants of its own

## Indications for use
EmboCube Embolization Gelatin is indicated for use in embolization of hypervascular tumors.

Source page: https://510kreport.com/device/K181021
Methodology: https://510kreport.com/methodology