Cleared Traditional

K040498 - MYSHELL

K040498 is an FDA 510(k) clearance for MYSHELL, manufactured by Sedat S.A.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K040498 · Sedat S.A. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K040498

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
Combination Product No
PCCP Authorized No
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.

DTL Device Classification - Class 2, Special Controls

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 132
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K040498.
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TERUMO CIRCUIT CONNECTORS
K041697 · Terumo Cardiovascular Systems Corporation · Aug 2004
NOVOSCI TUBING AND CONNECTORS WITH NOVOCOAT TREATMENT
K033328 · Novosci Corp. · Jan 2004
RAPIDO CUT-A-WAY ROTATING HEMOSTASIS VALVE
K031688 · Guidant Corporation · Jul 2003
IS-1 HEMOSTASIS VALVE, MODEL 6799
K031398 · Guidant Corp. · May 2003
K040498 · MYSHELL
Download PDF FDA Summary Sedat S.A.