# K092064: Soundstar 3D Ultrasound Catheter, Model M-5723-12

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Aug 7, 2009 after 30 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: 4 generations back to K921148 (1992). 7 ancestors in all.
9 later devices descend from it; 3 cite it directly.
1 of 17 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070242: Soundstar 3D Ultrasound Catheter, Model M-5723-05, Biosense Webster, Inc. (2007) Summary page 2.
- K071234: Acunav Diagnostic Ultrasound Catheter 8F and 10F, Siemens Medical Solutions USA, Inc. (2007) Summary page 2.

## Most influential descendants
- 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
- K101138: Soundstar 3D Ultrasound Catheter Model M-5723-12 (2010), 1 descendant of its own
- K254149: Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) (2026), 0 descendants of its own

## Indications for use
The Biosense Webster SOUNDSTAR 3D Diagnostic 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 9.7 or greater, the SOUNDSTAR 3D Catheter provides location information.

Source page: https://510kreport.com/device/K092064
Methodology: https://510kreport.com/methodology