Cleared Traditional

K190175 - S-MAK XL

K190175 is the FDA 510(k) clearance for S-MAK XL by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code DRE) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K190175 · Merit Medical Systems, Inc. · Cardiovascular device
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Apr 2019
Decision
68d
Days
Class 2
Risk

K190175 is an FDA 510(k) clearance for the S-MAK XL. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on April 10, 2019 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K190175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2019
Decision Date April 10, 2019
Days to Decision 68 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
57d faster than avg
Panel avg: 125d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 43
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K190175.
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
K192283 · Medron, LLC · May 2020
Super Sheath
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Sterile Dilator
K192195 · Galt Medical Corp. · Sep 2019
ExpanSure Transseptal Dilation System
K182064 · Baylis Medical Company, Inc. · Mar 2019
Dilator Sets
K183036 · Cook Incorporated · Dec 2018
MC3 Vascular Access Kit 21030
K182914 · Mc3 Incorporated · Oct 2018