# K240873: TEMBO Embolic System

- Pathway: 510(k) (Traditional)
- Applicant: Instylla, Inc.
- Decided: Dec 16, 2024 after 262 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.
1 later device descends from it; 1 cites it directly.
0 of 11 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 5.

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

## Indications for use
The TEMBO Embolic System is a gelatin agent intended for use in the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.

Source page: https://510kreport.com/device/K240873
Methodology: https://510kreport.com/methodology