# K203251: SOLOPASS System

- Pathway: 510(k) (Traditional)
- Applicant: Intravent Medical Partners, LP
- Decided: Aug 27, 2021 after 296 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K935595 (1995). 33 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083597: Sonowand Invite, Sonowand AS (2009) Summary page 4.
- K112469: General Prupose Localizers and Adapters-New Accessories for Sonowand System, Sonowand AS (2012) Summary page 4.

## Most influential descendants
- K251317: SOLOPASS 2.0 System (2025), 0 descendants of its own

## Indications for use
The SOLOPASS® System is a tool that obtains ultrasound images and positional data to provide intra-procedural, image guided localization and navigation, to aid in the frontal placement of an intra-ventricular catheter.

Source page: https://510kreport.com/device/K203251
Methodology: https://510kreport.com/methodology