Cleared Traditional

K113148 - E-PASS

K113148 is an FDA 510(k) clearance for E-PASS, manufactured by Synexmed(Shenzhen)Company Limited. 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.

K113148 · Synexmed(Shenzhen)Company Limited · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2012
Decision
127d
Days
Class 2
Risk

K113148 is an FDA 510(k) clearance for the E-PASS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Synexmed(Shenzhen)Company Limited (Shenzhen, CN). The FDA issued a Cleared decision on February 28, 2012 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 Synexmed(Shenzhen)Company Limited devices

FDA 510(k) Submission Details - K113148

510(k) Number K113148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2011
Decision Date February 28, 2012
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.

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 84
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