# K112050: Soundstar Eco Diagnostic Ultrasound Catheter

- Pathway: 510(k) (Special)
- Applicant: Biosense Webster, Inc.
- Decided: Nov 18, 2011 after 123 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: 5 generations back to K921148 (1992). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
1 of 14 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 1.
- K092064: Soundstar 3D Ultrasound Catheter, Model M-5723-12, Biosense Webster, Inc. (2009) Summary page 1.

## Most influential descendants
- K240050: SOUNDSTAR™ CRYSTAL Ultrasound Catheter (2024), 1 descendant of its own
- K223766: NUVISION™ NAV Ultrasound Catheter (2023), 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
- K250545: Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) (2025), 0 descendants of its own
- K241540: NUVISION™ Ultrasound Catheter; NUVISION™ NAV Ultrasound Catheter (2024), 0 descendants of its own

## Indications for use
The Biosense Webster SOUNDSTAR® eco 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 compatible CARTO® 3 EP Navigation Systems, the SOUNDSTAR® eco Catheter provides location information. Please refer to the Compatibility Matrix Insert for Compatible CARTO® 3 Systems as each catheter is compatible with a specific version of CARTO® 3 and is not backwards compatible with previous versions of CARTO® 3 EP Navigation Systems.

Source page: https://510kreport.com/device/K112050
Methodology: https://510kreport.com/methodology