# K260432: Ruby Intravascular Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Venocare, Inc.
- Decided: Sep 2, 2026 after 203 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: 9 generations back to K854773 (1986). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243105: Ruby Intravascular Catheter, Venocare, Inc. (2025) Summary page 6.

## 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 20 Gauge RUBY Intravascular Catheter is indicated for use in pediatric patients (with body mass higher or equal to 10 kg) and adults. The 22 Gauge and 24 Gauge RUBY Intravascular Catheter are indicated for use in pediatric patients (with body mass higher or equal to 3.5 kg) and adults.

Source page: https://510kreport.com/device/K260432
Methodology: https://510kreport.com/methodology