Cleared Traditional

K913956 - BLOOD CARDIOPLEGIA HEAT EXCHANGER

K913956 is the FDA 510(k) clearance for BLOOD CARDIOPLEGIA HEAT EXCHANGER by Bentley Laboratories, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K913956 · Bentley Laboratories, Inc. · Cardiovascular device
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Jan 1992
Decision
134d
Days
Class 2
Risk

K913956 is an FDA 510(k) clearance for the BLOOD CARDIOPLEGIA HEAT EXCHANGER, MODEL #HE-30. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on January 17, 1992 after a review of 134 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 Bentley Laboratories, Inc. devices

Submission Details

510(k) Number K913956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1991
Decision Date January 17, 1992
Days to Decision 134 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 125d · This submission: 134d
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 126
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K913956.
MVR COLLAPSIBLE VENOUS RESERVOIR BAG
K920774 · Medtronic Vascular · Oct 1992
NEW COBE CARDIOPLEGIA SYSTEM
K920312 · Cobe Cardiovascular, Inc. · Oct 1992
AUTOTRANSFUSION BLOOD COLLECTION RESERVOIR
K915737 · Electromedics, Inc. · Sep 1992
VENOUS RESERVOIR BAG MODEL NO. BMR-250(TM)
K913692 · Bentley Laboratories, Inc. · Nov 1991
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · Medtronic Vascular · Aug 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · Shiley, Inc. · Aug 1991