Cleared Traditional

K852382 - CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR

K852382 is an FDA 510(k) clearance for CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION ..., manufactured by American Bentley. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K852382 · American Bentley · Cardiovascular device
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Sep 1985
Decision
112d
Days
Class 2
Risk

K852382 is an FDA 510(k) clearance for the CARDIOTOMY/MEDIASTINAL AUTOTRANSFUSION RESERVOIR. 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 September 25, 1985 after a review of 112 days - within the typical 510(k) review window.

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: 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 - K852382

510(k) Number K852382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1985
Decision Date September 25, 1985
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

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 143
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K852382.
BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR
K862920 · C.R. Bard, Inc. · Sep 1986
MODIFIED CARDIOTOMY RESERVOIR 5M1470
K862357 · 3M Health Care, Sarns · Aug 1986
SHILEY VENOUS RESERVOIR
K854841 · Shiley, Inc. · Feb 1986
VENOUS RESERVOIR BAG BMR-1600
K851376 · American Bentley · Jun 1985
VENUOS RESERVOIR BAG BMR-1900
K851401 · American Bentley · Jun 1985
ACR 2500 CARDIOTOMY RESERVOIR FILTER
K842391 · Electromedics, Inc. · May 1985