Cleared Traditional

K122088 - MERIT ONE SNARE SYSTEM

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

K122088 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K122088

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.

MMX Device Classification - Class 2, Special Controls

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 23
Devices cleared under the same product code (MMX) and FDA review panel - the closest regulatory comparables to K122088.
EN Snare Endovascular Snare System
K151497 · Merit Medical Systems, Inc. · Jul 2015
ONE Snare Endovascular Microsnare System
K142265 · Merit Medical Systems, Inc. · Nov 2014
CRUX SNARE FILTER RETRIEVAL SET
K133681 · Volcano Corporation · Jan 2014
FOURSNARE VASCULAR RETRIEVAL SNARE
K112185 · Cook, Inc. · Nov 2011
EN SNARE ENDOVASCULAR SNARE SYSTEM
K092343 · Merit Medical Systems, Inc. · Aug 2009
EN-SNARE ENDOVASCULAR SNARE AND CATHETER
K021606 · Medical Device Technologies, Inc. · May 2002