# K260508: LOBO Vascular Occlusion System

- Pathway: 510(k) (Traditional)
- Applicant: Okami Medical, Inc.
- Decided: Apr 10, 2026 after 52 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: 1 generation back to K192083 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192083: Okami Medical LOBO Vascular Occlusion System, Okami Medical (2019) Summary page 5.

## Indications for use
The Okami Medical LOBO Vascular Occlusion System is intended for use to obstruct or reduce the rate of blood flow in arteries of the peripheral vasculature. The device is not indicated for use in blood vessels where crush or bend forces are anticipated (e.g. joint areas, superficial vasculature).

Source page: https://510kreport.com/device/K260508
Methodology: https://510kreport.com/methodology