Cleared Traditional

K831157 - BLOOD CARDIOPLEGIA STAINLESS STEEL COOL

K831157 is the FDA 510(k) clearance for BLOOD CARDIOPLEGIA STAINLESS STEEL COOL by American Bentley. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K831157 · American Bentley · Cardiovascular device
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May 1983
Decision
31d
Days
Class 2
Risk

K831157 is an FDA 510(k) clearance for the BLOOD CARDIOPLEGIA STAINLESS STEEL COOL. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by American Bentley (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983 after a review of 31 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bentley devices

Submission Details

510(k) Number K831157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1983
Decision Date May 09, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
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 K831157.
LAL TEST RELEASE & BONCHEK CAR/JACKET
K833555 · Shiley, Inc. · Feb 1984
CARDIOPLEGIA SYSTEM CCS-XXX SERIES
K833662 · Gish Biomedical, Inc. · Dec 1983
HYPOTHERMIC MYCARDIAL PROTECTION DEV
K832417 · 3M Health Care, Sarns · Oct 1983
CLEAR CARDIOPLEJIA DELIVERY SYSTEM
K823451 · 3M Health Care, Sarns · Jan 1983
JACKET & SET
K823533 · Shiley, Inc. · Dec 1982
COBE HEAT EXCHANGER RESERVOIR MODULE
K812093 · Cobe Laboratories, Inc. · Aug 1981