Cleared Traditional

K854113 - CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH

K854113 is an FDA 510(k) clearance for CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH, manufactured by American Bentley. The device is a Class 1 Cardiovascular device with product code KRI cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K854113

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
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 30
Devices cleared under the same product code (KRI) and FDA review panel - the closest regulatory comparables to K854113.
ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE
K862549 · American Bentley · Jul 1986
STABLELINE
K860298 · Cardio Metrics, Inc. · Apr 1986
ADJUSTABLE OXYGENATOR HOLDER MODEL NO. BCM-HL
K860672 · American Bentley · Mar 1986
GAMBRO DIGITAL TELETHERMOMETER TTH 10-200
K852455 · Gambro, Inc. · Sep 1985
COBE GAS FILTER
K851289 · Cobe Laboratories, Inc. · Jun 1985
TUBE TENDER
K841296 · The Anspach Effort, Inc. · Jun 1984