# K092014: Solopath Balloon Expandable Transfemoral Introducer

- Pathway: 510(k) (Traditional)
- Applicant: Onset Medical Corporation
- Decided: Oct 8, 2009 after 94 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
3 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K100819: The Solopath Balloon Expandable Transfemoral Introducer (2010), 11 descendants of its own
- K152225: Edwards eSheath Introducer Set (2015), 4 descendants of its own
- K162184: Edwards eSheath Introducer Set (2016), 3 descendants of its own
- K200258: Edwards eSheath Introducer Set (2020), 2 descendants of its own
- K244046: Edwards eSheath Optima introducer set (2025), 1 descendant of its own

## Indications for use
The SoloPathTM Balloon Expandable TransFemoral Introducer is intended to be inserted percutaneously into the femoral artery, over a guidewire, and once expanded, to provide a guide for catheters and /or devices introduced into the femoral iliac arteries.

Source page: https://510kreport.com/device/K092014
Methodology: https://510kreport.com/methodology