Cleared Traditional

K844367 - CARDIOTOMY RESERVOIR W/FILTER BCR-2500

K844367 is the FDA 510(k) clearance for CARDIOTOMY RESERVOIR W/FILTER BCR-2500 by American Bentley. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K844367 · American Bentley · Cardiovascular device
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Jan 1985
Decision
62d
Days
Class 2
Risk

K844367 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR W/FILTER BCR-2500. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by American Bentley (Irvine, US). The FDA issued a Cleared decision on January 14, 1985 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 K844367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 14, 1985
Days to Decision 62 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 125d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 78
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K844367.
CARDIOTOMY RESERVOIR BRS-XXX SERIES &
K843888 · Gish Biomedical, Inc. · Feb 1985
SHILEY HARDSHELL VENOUS RESERVOIR W/INT
K843232 · Shiley, Inc. · Jan 1985
VENOUS RESERVOIR VRS-XXX SERIES
K844229 · Gish Biomedical, Inc. · Jan 1985
SHILEY VENOUS RESERVOIR
K842337 · Shiley, Inc. · Aug 1984
SHILEY CARDIOTOMY RESERVOIR W/FILTER
K842711 · Shiley, Inc. · Aug 1984
WILLIAM HARVEY H-4720 NON-FILTERED CAR
K841175 · C.R. Bard, Inc. · Apr 1984