# K152498: SoloPath Re-Collapsible Access System

- Pathway: 510(k) (Traditional)
- Applicant: Onset Medical Corporation
- Decided: Jan 5, 2016 after 126 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 2 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K032073 (2003). 7 ancestors in all.
No later device cites it as a predicate yet.
2 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121404: Solopath RE-Collapsible Access System, Onset Medical Corporation (2013) Summary page 6.

## Recalls of this device
- Apr 26, 2019 · Class I · Z-1375-2019: 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
- Apr 26, 2019 · Class I · Z-1376-2019: 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 SoloPath® Re-Collapsible Access System is indicated for percutaneous insertion into the femoral artery over a guidewire and, once expanded, to provide a guide for catheters and/or devices introduced into the femoral artery. The device may also be used to expand femoroiliac artery lesions to facilitate its use as an Access System.

Source page: https://510kreport.com/device/K152498
Methodology: https://510kreport.com/methodology