Cleared Traditional

K913994 - MONARCH(TM) INFLATION SYRINGE

K913994 is an FDA 510(k) clearance for MONARCH(TM) INFLATION SYRINGE, manufactured by Merit Medical Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MAV cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K913994 · Merit Medical Systems, Inc. · Cardiovascular device
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Feb 1992
Decision
151d
Days
Class 2
Risk

K913994 is an FDA 510(k) clearance for the MONARCH(TM) INFLATION SYRINGE. Classified as Syringe, Balloon Inflation (product code MAV), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 4, 1992 after a review of 151 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1650 - 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 - K913994

510(k) Number K913994 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1991
Decision Date February 04, 1992
Days to Decision 151 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d slower than avg
Panel avg: 125d · This submission: 151d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAV Device Classification - Class 2, Special Controls

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 45
Devices cleared under the same product code (MAV) and FDA review panel - the closest regulatory comparables to K913994.
IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING
K940425 · Imagyn Medical, Inc. · Aug 1994
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
K922573 · Boston Scientific Corp · Dec 1992
ACS ANGIOTRAK(TM) SYSTEM
K921719 · Advanced Cardiovascular Systems, Inc. · Aug 1992
CORDIS INFLATOR DEVICE
K912644 · Cordis Corp. · Sep 1991
MEDFLATOR INFLATION SYSTEM
K910958 · Medex, Inc. · Jul 1991
BIPOLAR FORCEPS
K912544 · Everest Medical Corp. · Jun 1991