# K213200: Solus Gold Embolization Device

- Pathway: 510(k) (Traditional)
- Applicant: Artio Medical, Inc.
- Decided: Mar 21, 2022 after 173 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: 17 generations back to K951256 (1995). 87 ancestors in all.
No later device cites it as a predicate yet.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141313: Reverse Medical Micro Vascular Plug System, Reverse Medical Corporation (2014) Summary page 4.
- K150108: Reverse Medical Micro Vascular Plug System, Reverse Medical Corporation (2015) Summary page 5.

## Indications for use
The Solus Gold Embolization Device is indicated to obstruct or reduce the rate of blood flow in the peripheral vasculature.

Source page: https://510kreport.com/device/K213200
Methodology: https://510kreport.com/methodology