# K253677: Tembo Embolic System

- Pathway: 510(k) (Special)
- Applicant: Instylla, Inc.
- Decided: Dec 15, 2025 after 24 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 K961923 (1996). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240873: TEMBO Embolic System, Instylla, Inc. (2024) Summary page 5.

## 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/K253677
Methodology: https://510kreport.com/methodology