Cleared Abbreviated

K031691 - MERIT MAK (MINI ACCESS KIT)

K031691 is an FDA 510(k) clearance for MERIT MAK (MINI ACCESS KIT), manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Abbreviated 510(k) pathway after a 93-day FDA review.

K031691 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
93d
Days
Class 2
Risk

K031691 is an FDA 510(k) clearance for the MERIT MAK (MINI ACCESS KIT). 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 September 3, 2003 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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.

FDA 510(k) Submission Details - K031691

510(k) Number K031691 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date September 03, 2003
Days to Decision 93 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
32d faster than avg
Panel avg: 125d · This submission: 93d
Pathway characteristics
Standards-based clearance path.

DRE Device Classification - Class 2, Special Controls

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 104
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K031691.
EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0
K061000 · Cook Vascular, Inc. · May 2006
SUPER SHEATH INTRODUCER SHEATH
K052557 · Togo Medikit Co., Ltd. · Jan 2006
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
GELBFISH FLEX VASCULAR DILATOR
K030260 · Vascumetrix, LLC · Feb 2003
MODIFICATION TO GELBFISH VASCULAR DILATORS
K023507 · Vascumetrix, LLC · Nov 2002
GELBISH VASCULAR DILATOR
K012256 · Vascumetrix, LLC · Dec 2001
K031691 · MERIT MAK (MINI ACCESS KIT)
Download PDF FDA Summary Merit Medical Systems…