# K052517: Site-Rite 5 Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 29, 2005 after 15 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K850478 (1985). 4 ancestors in all.
139 later devices descend from it; 2 cite it directly.
0 of 144 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032135: Site-Rite IV Ultrasound System, Dymax Corp (2003) Summary page 3.

## Most influential descendants
- K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6 (2007), 136 descendants of its own
- K142443: Site-Rite 6 Ultrasound System with Pinpoint GT Technology (2014), 64 descendants of its own
- K092619: Etrax Needle System, Etrax Variable Angle Needle Guidance System, Virtutrax Universal Tracker (2009), 61 descendants of its own
- K152758: Venue 50 (2015), 55 descendants of its own
- K160277: LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 (2016), 47 descendants of its own

## Indications for use
The Site-Rite®5 Ultrasound System with associated probe and accessories provide ultrasound guidance for placement of needles and catheters in vascular structures. Ultrasound guidance may occur intraoperatively or percutaneously. Ultrasound imaging of vascular structures, various organs and structures of the body may also be performed.

Source page: https://510kreport.com/device/K052517
Methodology: https://510kreport.com/methodology