Cleared Traditional

CHECK VALVE (FITTING) (K933084) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K933084 · Merit Medical Systems, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Mar 1994
Decision
273d
Days
Class 2
Risk

K933084 is an FDA 510(k) clearance for the CHECK VALVE (FITTING). Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Merit Medical Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 23, 1994 after a review of 273 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 K933084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1993
Decision Date March 23, 1994
Days to Decision 273 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 125d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 136
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K933084.
MEDLINE STOPCOCK AND MANIFOLD
K120069 · Medline Industries, Inc. · Apr 2012
6248VAL ADJUSTABLE VALVE
K052459 · Medtronic Vascular · Jan 2006
SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM
K893683 · 3M Company · Aug 1989
USCI TANDEM ADAPTER
K884200 · C.R. Bard, Inc. · Dec 1988
LUER LOCK SKIRT
K862451 · Hewlett-Packard Co. · Oct 1986
CORDIS ANGIOPLASTY HEMOSTASIS DEVICES
K863177 · Cordis Corp. · Oct 1986