# K221390: BNLE Access Guidewire

- Pathway: 510(k) (Traditional)
- Applicant: Biomerics Nle
- Decided: Apr 28, 2023 after 350 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: 6 generations back to K011084 (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)
- K112631: Vsi Guidewire, Vascular Solutions, Inc. (2011) Summary page 4.

## Indications for use
The BNLE Access Guidewire is intended for percutaneous entry of peripheral vessels using the Seldinger Technique. This device is not intended for use in the coronary or cerebral vasculature.

Source page: https://510kreport.com/device/K221390
Methodology: https://510kreport.com/methodology