Cleared Traditional

K122088 - MERIT ONE SNARE SYSTEM

K122088 is the FDA 510(k) clearance for MERIT ONE SNARE SYSTEM by Merit Medical Systems, Inc.. It is a Class 2 Cardiovascular device (product code MMX) cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K122088 · Merit Medical Systems, Inc. · Cardiovascular device
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Dec 2012
Decision
142d
Days
Class 2
Risk

K122088 is an FDA 510(k) clearance for the MERIT ONE SNARE SYSTEM. Classified as Device, Percutaneous Retrieval (product code MMX), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 5, 2012 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Systems, Inc. devices

Submission Details

510(k) Number K122088 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2012
Decision Date December 05, 2012
Days to Decision 142 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
17d slower than avg
Panel avg: 125d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMX Device, Percutaneous Retrieval
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - MMX Device, Percutaneous Retrieval

All 19
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K122088.
Recovery Cone Removal System
K152136 · C.R. Bard, Inc. · Feb 2016
EN Snare Endovascular Snare System
K151497 · Merit Medical Systems, Inc. · Jul 2015
ONE Snare Endovascular Microsnare System
K142265 · Merit Medical Systems, Inc. · Nov 2014
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · Cook, Inc. · Nov 2011
EN SNARE ENDOVASCULAR SNARE SYSTEM
K092343 · Merit Medical Systems, Inc. · Aug 2009