# K112629: Onset Access Catheter System

- Pathway: 510(k) (Traditional)
- Applicant: Onset Medical Corporation
- Decided: Oct 11, 2011 after 32 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K010954 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102418: Reverse Medical Report Guide Catheter System, Reverse Medical Corporation (2011) Summary page 2.

## Indications for use
The Onset Medical Access Catheter System is indicated for the introduction of interventional/diagnostic devices into the peripheral, coronary and neuro vasculature.

Source page: https://510kreport.com/device/K112629
Methodology: https://510kreport.com/methodology