Cleared Traditional

K942582 - SORIN BLOOD CARDIOPLEGIA CONSOLE (FDA 510(k) Clearance)

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

K942582 · Sorin Biomedical, Inc. · Cardiovascular device
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Jan 1995
Decision
240d
Days
Class 2
Risk

K942582 is an FDA 510(k) clearance for the SORIN BLOOD CARDIOPLEGIA CONSOLE. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Sorin Biomedical, Inc. (Irvine, US). The FDA issued a Cleared decision on January 27, 1995 after a review of 240 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Sorin Biomedical, Inc. devices

Submission Details

510(k) Number K942582 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1994
Decision Date January 27, 1995
Days to Decision 240 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
115d slower than avg
Panel avg: 125d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 51
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