Cleared Traditional

NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856) - FDA 510(k) Clearance

Class I Cardiovascular device.

K892856 · Acacia Laboratories, Inc. · Cardiovascular device
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Nov 1989
Decision
204d
Days
Class 1
Risk

K892856 is an FDA 510(k) clearance for the NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by Acacia Laboratories, Inc. (Santa Ana, US). The FDA issued a Cleared decision on November 8, 1989 after a review of 204 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4200 - 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 Acacia Laboratories, Inc. devices

Submission Details

510(k) Number K892856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1989
Decision Date November 08, 1989
Days to Decision 204 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 125d · This submission: 204d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KRI Accessory Equipment, Cardiopulmonary Bypass
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KRI Accessory Equipment, Cardiopulmonary Bypass

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