# K042445: Site-Rite Needle Guide Kits and Probe Cover Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bard Access Systems, Inc.
- Decided: Oct 19, 2004 after 40 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: 2 generations back to K844472 (1985). 3 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931403: Siterite Needle Guide (Modified), Dymax Corp (1993) Summary page 1.
- K970889: Ultrasound Transducer Drape, Protek Medical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K120882: Site Rite Prevue Ultrasound System and Pinpoint Needle Guide (2012), 8 descendants of its own
- 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
- K171348: Pinpoint GT Needle Guide Kits (2017), 2 descendants of its own

## Indications for use
Site-Rite Needle Guide Kits and Site-Rite Probe Cover Kits are intended to be used with Site-Rite Ultrasound Systems. The probe cover sheathes the transducer and isolates a site of surgical penetration from microbial and other contamination. The needle guide provides 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.

Source page: https://510kreport.com/device/K042445
Methodology: https://510kreport.com/methodology