Cleared Traditional

MYSHELL (K040498) - FDA 510(k) Clearance

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

K040498 · Sedat S.A. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 2004
Decision
127d
Days
Class 2
Risk

K040498 is an FDA 510(k) clearance for the MYSHELL. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Sedat S.A. (Charlestown, US). The FDA issued a Cleared decision on July 2, 2004 after a review of 127 days - within the typical 510(k) review window.

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 Sedat S.A. devices

Submission Details

510(k) Number K040498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2004
Decision Date July 02, 2004
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 24
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K040498.
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R
K100319 · Merit Medical Systems, Inc. · Apr 2010
HEMOSTASIS VALVE
K072556 · Merit Medical Systems, Inc. · Nov 2007
6248VAL ADJUSTABLE VALVE
K052459 · Medtronic Vascular · Jan 2006
MBA
K993057 · Merit Medical Systems, Inc. · Oct 1999
CHECK VALVE (FITTING)
K933084 · Merit Medical Systems, Inc. · Mar 1994
STOPCOCK (ONE-PORT MANIFOLD)
K934123 · Merit Medical Systems, Inc. · Nov 1993