# K140504: Accucath BC Intravascular Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Pathways, Inc.
- Decided: Jul 17, 2014 after 140 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: 5 generations back to K854773 (1986). 12 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110443: BD Insyte Autoguard BC, Becton, Dickinson & CO (2011) Summary page 2.
- K012128: Protectiv Acuvance IV Catheter System, Ethicon Endo-Surgery, Inc. (2001) Summary page 2.
- K112347: Rapid Intravascular Catheter Start System 22 Gauge / 20 Gauge / 18 Gauge, Vascular Pathways, Inc. (2011) Summary page 1.

## Most influential descendants
- K153298: AccuCath Intravascular Catheter (2015), 5 descendants of its own
- K162894: AccuCath Intravascular Catheter (2016), 4 descendants of its own
- K243105: Ruby Intravascular Catheter (2025), 1 descendant of its own
- K260432: Ruby Intravascular Catheter (2026), 0 descendants of its own
- K233106: AccuCath Ace™ Intravascular Catheter (2024), 0 descendants of its own

## Indications for use
The AccuCath BC Intravascular Catheter System is inserted into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. This device may be used with consideration given to adequacy of vascular anatomy, appropriateness of the solution being infused, and duration of therapy. The AccuCath BC is suitable for use with low pressure power injectors having a maximum pressure setting of 300 psi and maximum flow rate of 6mL/second.

Source page: https://510kreport.com/device/K140504
Methodology: https://510kreport.com/methodology