# K121404: Solopath RE-Collapsible Access System

- Pathway: 510(k) (Traditional)
- Applicant: Onset Medical Corporation
- Decided: May 3, 2013 after 358 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
Longest line of descent: 3 generations back to K032073 (2003). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 8 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.
- K100819: The Solopath Balloon Expandable Transfemoral Introducer, Onset Medical Corporation (2010) Summary page 1.
- K093791: Gore Dryseal Sheath, W. L. Gore & Associates, Inc. (2010) Summary page 1.
- (no number) Cook® Extra Large Check-Flo® Introducer: named in the summary without a submission number

## Most influential descendants
- K152498: SoloPath Re-Collapsible Access System (2016), 0 descendants of its own

## Indications for use
The SoloPath® Re-Collapsible Access System 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 artery.

Source page: https://510kreport.com/device/K121404
Methodology: https://510kreport.com/methodology