Cleared Traditional

K854113 - CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH (FDA 510(k) Clearance)

Class I Cardiovascular device.

K854113 · American Bentley · Cardiovascular device
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Jan 1986
Decision
92d
Days
Class 1
Risk

K854113 is an FDA 510(k) clearance for the CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH. Classified as Accessory Equipment, Cardiopulmonary Bypass (product code KRI), Class I - General Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on January 8, 1986 after a review of 92 days - within the typical 510(k) review window.

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 American Bentley devices

Submission Details

510(k) Number K854113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1985
Decision Date January 08, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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.