# K203657: Vu-Path Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Crystalline Medical
- Decided: Jun 25, 2021 after 192 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K850478 (1985). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142443: Site-Rite 6 Ultrasound System with Pinpoint GT Technology, C.R. Bard, Inc. (2014) Summary page 4.

## Indications for use
The Vu-Path Ultrasound System with associated probe and accessories provide ultrasound guidance for the placement of needles and catheters in vascular structures adults aged 22 and older. Ultrasound imaging of vascular structures and surrounding tissue may also be performed. The ultrasound probe is only intended to be placed on the surface of the skin and should not be advanced percutaneously. The device provides B-Mode and Color Doppler modes of operation. The Vu-Path Ultrasound system needle guidance technology is indicated for use by appropriately-trained healthcare professionals to provide them with visual tools for passive tracking of a needle with respect to ultrasound image data.

Source page: https://510kreport.com/device/K203657
Methodology: https://510kreport.com/methodology