# K192480: Torpedo Gelatin Foam

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, S.A.
- Decided: Nov 21, 2019 after 72 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: 6 generations back to K961923 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183120: EmboCube Embolization Gelatin, Biosphere Medical, S.A. (2019) Summary page 4.

## Indications for use
Torpedo Gelatin Foam 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/K192480
Methodology: https://510kreport.com/methodology