# K254137: InQwire Amplatz Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Ireland, Ltd.
- Decided: May 22, 2026 after 151 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: 4 generations back to K002289 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163575: Inqwire Diagnostic Guide Wire, Merit Medical Systems, Inc. (2017) Summary page 6.
- K170700: Inqwire Diagnostic Guide Wire, Merit Medical Systems, Inc. (2017) Summary page 6.

## Indications for use
Merit Medical guide wires are used to facilitate the placement of devices during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K254137
Methodology: https://510kreport.com/methodology