Cleared Traditional

K892856 - NEWMARK(TM) CORONARY ARTERY BYPASS GRAF...

K892856 is an FDA 510(k) clearance for NEWMARK(TM) CORONARY ARTERY BYPASS GRAF..., manufactured by Acacia Laboratories, Inc.. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 204-day FDA review.

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

FDA 510(k) Submission Details - K892856

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.

KRI Device Classification - Class 1, General Controls

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

All 27
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