Cleared Traditional

K870804 - CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100

K870804 is an FDA 510(k) clearance for CARDIOPLEGIA HEAT EXCHANGER MODEL NO. H..., manufactured by American Bentley. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K870804

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
Combination Product No
PCCP Authorized No
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.

DTR Device Classification - Class 2, Special Controls

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 83
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K870804.
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
ELECTROMEDICS D1079E
K873561 · Electromedics, Inc. · Nov 1987
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