Cleared Traditional

K254137 - InQwire Amplatz Guide Wire

K254137 is an FDA 510(k) clearance for InQwire Amplatz Guide Wire, manufactured by Merit Medical Ireland, Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K254137 · Merit Medical Ireland, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
151d
Days
Class 2
Risk

K254137 is an FDA 510(k) clearance for the InQwire Amplatz Guide Wire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Ireland, Ltd. (Galway, IE). The FDA issued a Cleared decision on May 22, 2026 after a review of 151 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Merit Medical Ireland, Ltd. devices

FDA 510(k) Submission Details - K254137

510(k) Number K254137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2025
Decision Date May 22, 2026
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K254137.
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