# K070242: Soundstar 3D Ultrasound Catheter, Model M-5723-05

- Pathway: 510(k) (Traditional)
- Applicant: Biosense Webster, Inc.
- Decided: May 15, 2007 after 95 days
- Product code: OBJ (Catheter, Ultrasound, Intravascular)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 K921148 (1992). 5 ancestors in all.
14 later devices descend from it; 5 cite it directly.
1 of 20 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033650: Acunav 90/10 Diagnostic Ultrasound Catheter, Siemens Medical Solutions USA, Inc. (2004) Summary page 1.
- K954390: Cordis Wester Star Catheter, Cordis Webster, Inc. (1995) Summary page 1.

## Most influential descendants
- K092064: Soundstar 3D Ultrasound Catheter, Model M-5723-12 (2009), 9 descendants of its own
- K112050: Soundstar Eco Diagnostic Ultrasound Catheter (2011), 5 descendants of its own
- K240050: SOUNDSTAR™ CRYSTAL Ultrasound Catheter (2024), 1 descendant of its own
- K223766: NUVISION™ NAV Ultrasound Catheter (2023), 1 descendant of its own
- K110076: Reprocessed 3D Diagnostic Ultrasound Catheter (2011), 1 descendant of its own

## Indications for use
The Biosense Webster SOUNDSTAR 3D Ultrasound Catheter and related accessory devices are indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. When used with the CARTO XP EP Navigation System Version 9 or greater, the SOUNDSTAR 3D Ultrasound Catheter provides location information.

Source page: https://510kreport.com/device/K070242
Methodology: https://510kreport.com/methodology