Cleared Traditional

K963756 - IBC CARDIAC SUCTION WARD (FDA 510(k) Clearance)

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

K963756 · International Biophysics Corp. · Cardiovascular device
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Nov 1997
Decision
423d
Days
Class 2
Risk

K963756 is an FDA 510(k) clearance for the IBC CARDIAC SUCTION WARD. Classified as Sucker, Cardiotomy Return, Cardiopulmonary Bypass (product code DTS), Class II - Special Controls.

Submitted by International Biophysics Corp. (Austin, US). The FDA issued a Cleared decision on November 14, 1997 after a review of 423 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4420 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all International Biophysics Corp. devices

Submission Details

510(k) Number K963756 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1996
Decision Date November 14, 1997
Days to Decision 423 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
298d slower than avg
Panel avg: 125d · This submission: 423d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4420
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.