# K243479: EchoGuide (Version 1)

- Pathway: 510(k) (Traditional)
- Applicant: Sonavex, Inc.
- Decided: Apr 23, 2025 after 166 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: 22 generations back to K935595 (1995). 209 ancestors in all.
No later device cites it as a predicate yet.
0 of 210 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140126: Sonic Window, Analogic Corporation (2014) Summary page 5.
- K152554: Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology, C.R. Bard, Inc. (2015) Summary page 5.
- K190039: EchoSure Diagnostic Ultrasound System, Sonavex, Inc. (2019) Summary page 5.

## Indications for use
EchoGuide is a vascular ultrasound imaging device meant to aid in identification of the cannulation site on the skin of mature arteriovenous fistulas/grafts (AVFs/AVGs) in adult patients by appropriately trained healthcare providers in clinical settings. This device is not meant to replace the current standard of care cannulation methods.

Source page: https://510kreport.com/device/K243479
Methodology: https://510kreport.com/methodology