Cleared Special

INTELLISYSTEM II COLOR MONITOR (K993341) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K993341 · Merit Medical Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
20d
Days
Class 2
Risk

K993341 is an FDA 510(k) clearance for the INTELLISYSTEM II COLOR MONITOR. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on October 25, 1999 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Systems, Inc. devices

Submission Details

510(k) Number K993341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1999
Decision Date October 25, 1999
Days to Decision 20 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 125d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MAV Syringe, Balloon Inflation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1650
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 - MAV Syringe, Balloon Inflation

All 56
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K993341.
Everest 20 Inflation Device and 3-way Stopcock (AC2200)
K220773 · Medtronic Vascular · Apr 2022
Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit
K153038 · Medtronic, Inc. · Apr 2016
Presto Inflation Device
K143522 · C.R. Bard, Inc. · Jan 2015
ENCORE 26 ADVANTAGE KIT
K140745 · Boston Scientific Corp · Apr 2014
ENCORE 26 ADVANTAGE KIT
K123214 · Boston Scientific Corp · Nov 2012
ENCORE 26 ADVANTAGE KIT
K120694 · Boston Scientific Corp · Apr 2012