# K243105: Ruby Intravascular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Venocare, Inc.
- Decided: May 16, 2025 after 228 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K854773 (1986). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162894: AccuCath Intravascular Catheter, C.R. Bard, Inc. (2016) Summary page 5.

## Most influential descendants
- K260432: Ruby Intravascular Catheter (2026), 0 descendants of its own

## Indications for use
The RUBY Intravascular Catheter is inserted into a patient’s vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The RUBY Intravascular Catheter is suitable for use with power injectors. The RUBY Intravascular Catheter is indicated for use in pediatric patients (with body mass higher or equal to 10 kg) and adults.

Source page: https://510kreport.com/device/K243105
Methodology: https://510kreport.com/methodology