# K250203: SureAx-Guide™

- Pathway: 510(k) (Traditional)
- Applicant: Sureax Medical, LLC
- Decided: Oct 17, 2025 after 266 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K091385 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091385: Approach Hydro ST Wire Guide, Model HMW, Cook, Inc. (2009) Summary page 5.

## Indications for use
The SureAx-Guide guidewire is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature. The SureAx-Guide guidewire is not intended for use in the coronary or neuro vasculature.

Source page: https://510kreport.com/device/K250203
Methodology: https://510kreport.com/methodology