Cleared Traditional

K251385 - InQwire Super Stiff Guide Wire (IQSS32180J3) (FDA 510(k) Clearance)

Also includes:
InQwire Super Stiff Guide Wire (IQSS35F260S) InQwire Super Stiff Guide Wire (IQSS35F150S) InQwire Super Stiff Guide Wire (IQSS35F100S) InQwire Super Stiff Guide Wire (IQSS35F80S) InQwire Super Stiff Guide Wire (IQSS35F180S)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K251385 · Merit Medical Ireland, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2026
Decision
261d
Days
Class 2
Risk

K251385 is an FDA 510(k) clearance for the InQwire Super Stiff Guide Wire (IQSS32180J3). 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 January 21, 2026 after a review of 261 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

Submission Details

510(k) Number K251385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2025
Decision Date January 21, 2026
Days to Decision 261 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
136d slower than avg
Panel avg: 125d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 762
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K251385.
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
Enroute 0.014'' Transcarotid Guidewire
K253746 · Lake Region Medical · Mar 2026
EmeryGlide™ (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674 · Solo Pace, Inc. · Jan 2026
Lunderquist Extra Stiff Wire Guide
K251596 · William Cook Europe Aps · Nov 2025