Cleared Traditional

K870804 - CARDIOPLEGIA HEAT EXCHANGER MODEL NO. H...

K870804 is the FDA 510(k) clearance for CARDIOPLEGIA HEAT EXCHANGER MODEL NO. H... by American Bentley. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K870804 · American Bentley · Cardiovascular device
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Sep 1987
Decision
186d
Days
Class 2
Risk

K870804 is an FDA 510(k) clearance for the CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on September 1, 1987 after a review of 186 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 K870804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1987
Decision Date September 01, 1987
Days to Decision 186 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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.

Regulatory Peers - DTR Heat-exchanger, Cardiopulmonary Bypass

All 56
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K870804.
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332 · Shiley, Inc. · Sep 1988
SHILEY BCD PLUS HEAT EXCHANGER
K880663 · Shiley, Inc. · May 1988
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
K880451 · Scimed Life Systems, Inc. · Apr 1988
CCS-XXX, CARDIOPLEGIA ADMINISTRATION SETS
K871774 · Gish Biomedical, Inc. · Aug 1987
CPS-3000 CARDIOPLEGIA RESERVOIR
K861102 · Gish Biomedical, Inc. · May 1986
STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL
K860920 · Shiley, Inc. · May 1986