# K100819: The Solopath Balloon Expandable Transfemoral Introducer

- Pathway: 510(k) (Special)
- Applicant: Onset Medical Corporation
- Decided: Aug 2, 2010 after 132 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 1 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K092014 (2009). 1 ancestor in all.
11 later devices descend from it; 4 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)
- K092014: Solopath Balloon Expandable Transfemoral Introducer, Onset Medical Corporation (2009) Summary page 1.

## Most influential descendants
- 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
- K152194: transGlide Expandable Introducer (2016), 1 descendant of its own

## Recalls of this device
- Apr 26, 2019 · Class I · Z-1374-2019: There is a potential for dislodgement of the tip from the outer diameter of the sheath resulting in a loss of the smooth transition from the surface of the tip to the outer surface of the expandable s

## 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 for devices introduced into the femoral iliac arteries.

Source page: https://510kreport.com/device/K100819
Methodology: https://510kreport.com/methodology