# K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: May 30, 2012 after 68 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K945773 (1995). 37 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100402: Site-Rite Vision Ultrasound System, Bard Access Systems, Inc. (2010) Summary page 1.
- K071204: Site-Rite 6 Ultrasound System, Model Site-Rite 6, C.R. Bard, Inc. (2007) Summary page 1.
- K072515: Embrace Gel, Orison Corporation (2007) Summary page 2.
- K031894: Scantec Pad, Sonotech, Inc. (2003) Summary page 2.
- K042445: Site-Rite Needle Guide Kits and Probe Cover Kit, Bard Access Systems, Inc. (2004) Summary page 2.

## Most influential descendants
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology (2015), 6 descendants of its own
- K182281: Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech (2018), 4 descendants of its own
- K211193: BD Prevue II Peripheral Vascular Vascular Access System (2021), 2 descendants of its own
- K251673: X9 Ultrasound System (2025), 0 descendants of its own
- K243479: EchoGuide (Version 1) (2025), 0 descendants of its own

## Indications for use
The Site-Rite Prevue* Ultrasound System is intended to provide ultrasound imaging of the human body. Specific clinical applications include: *Adult Cephalic *Neonatal Cephalic *Pediatric .Peripheral Vessel The gel cap is intended for use as an ultrasound coupling medium for use with the Site-Rite Prevue* Ultrasound System. The device is intended for use with pediatrics and adults.I The needle guides are intended to provide guidance for a needle to intersect an ultrasound beam at a fixed distance below the skin to assist the medical practitioner in placing the tip of a needle in a specific structure. This device is intended for use with pediatrics and adults.

Source page: https://510kreport.com/device/K120882
Methodology: https://510kreport.com/methodology