Cleared Traditional

K934355 - ELECTROMEDICS BLOOD HEAT EXCHANGER

K934355 is an FDA 510(k) clearance for ELECTROMEDICS BLOOD HEAT EXCHANGER, manufactured by Electromedics, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K934355 · Electromedics, Inc. · Cardiovascular device
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Dec 1993
Decision
87d
Days
Class 2
Risk

K934355 is an FDA 510(k) clearance for the ELECTROMEDICS BLOOD HEAT EXCHANGER. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on December 3, 1993 after a review of 87 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 Electromedics, Inc. devices

FDA 510(k) Submission Details - K934355

510(k) Number K934355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1993
Decision Date December 03, 1993
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 125d · This submission: 87d
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 83
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K934355.
MYOCARDIAL PROTECTION SYSTEM
K953838 · Quest Medical, Inc. · Mar 1996
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
K944219 · Gish Biomedical, Inc. · Jun 1995
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267 · Cobe Cardiovascular, Inc. · Apr 1995
ROTATOR
K932251 · Merit Medical Systems, Inc. · Aug 1993
HE-30 GOLD
K931967 · Bentley Laboratories, Inc. · Jul 1993
BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
K925369 · Sorin Biomedica, Fiat, USA, Inc. · Mar 1993