Cleared Traditional

K923311 - CONDUCER HEAT EXCHANGER

K923311 is an FDA 510(k) clearance for CONDUCER HEAT EXCHANGER, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K923311 · 3M Health Care, Sarns · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Sep 1992
Decision
73d
Days
Class 2
Risk

K923311 is an FDA 510(k) clearance for the CONDUCER HEAT EXCHANGER. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on September 18, 1992 after a review of 73 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 3M Health Care, Sarns devices

FDA 510(k) Submission Details - K923311

510(k) Number K923311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1992
Decision Date September 18, 1992
Days to Decision 73 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
52d faster than avg
Panel avg: 125d · This submission: 73d
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 78
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K923311.
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · Electromedics, Inc. · Dec 1993
ROTATOR
K932251 · Merit Medical Systems, Inc. · Aug 1993
HE-30 GOLD
K931967 · Bentley Laboratories, Inc. · Jul 1993
LANCASTER COOLING JACKET, CAT. CODE #13500/13501
K913077 · Dlp, Inc. · Jan 1992
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
K913691 · Gish Biomedical, Inc. · Dec 1991
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
K914742 · Medtronic Vascular · Dec 1991