# K250079: Ruby XL System

- Pathway: 510(k) (Traditional)
- Applicant: Penumbra, Inc.
- Decided: Mar 14, 2025 after 60 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: 11 generations back to K951256 (1995). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173614: Penumbra Coil 400, Ruby Coil System, POD System, Penumbra, Inc. (2018) Summary page 5.

## Indications for use
The Ruby XL System is indicated for arterial and venous embolizations in the peripheral vasculature.

Source page: https://510kreport.com/device/K250079
Methodology: https://510kreport.com/methodology