Cleared Abbreviated

K182538 - Merit RadialFlo Arterial Catheter

K182538 is the FDA 510(k) clearance for Merit RadialFlo Arterial Catheter by Merit Medical Singapore Pte. , Ltd.. It is a Class 2 Cardiovascular device (product code FOZ) cleared through the Abbreviated 510(k) pathway after a 124-day FDA review.

K182538 · Merit Medical Singapore Pte. , Ltd. · Cardiovascular device
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Jan 2019
Decision
124d
Days
Class 2
Risk

K182538 is an FDA 510(k) clearance for the Merit RadialFlo Arterial Catheter. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Merit Medical Singapore Pte. , Ltd. (Singapore, SG). The FDA issued a Cleared decision on January 16, 2019 after a review of 124 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 880.5200 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Merit Medical Singapore Pte. , Ltd. devices

Submission Details

510(k) Number K182538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2018
Decision Date January 16, 2019
Days to Decision 124 days
Submission Type Abbreviated
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
1d faster than avg
Panel avg: 125d · This submission: 124d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

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