# K192211: SoundBite Console, SoundBite Active Wire 18

- Pathway: 510(k) (Traditional)
- Applicant: Soundbite Medical Solution, Inc.
- Decided: Jan 17, 2020 after 156 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K890505 (1989). 14 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092175: The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200, Flowcardia, Inc. (2010) Summary page 4.

## Most influential descendants
- K210839: SoundBite Crossing System - Peripheral (14P) (2021), 1 descendant of its own
- K230159: SoundBite® Crossing System XS Peripheral (2023), 0 descendants of its own

## Indications for use
SoundBite™ Crossing System -Peripheral is indicated to facilitate the intra-luminal placement of conventional guidewires or treatment devices beyond peripheral artery chronic total occlusions. The SoundBite™ Crossing System - Peripheral is not intended for use in the carotid arteries.

Source page: https://510kreport.com/device/K192211
Methodology: https://510kreport.com/methodology