Cleared Traditional

TOPICAL COOLING DEV. TCD. #27-999 (K800717) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800717 · Cobe Laboratories, Inc. · Cardiovascular device
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Apr 1980
Decision
16d
Days
Class 2
Risk

K800717 is an FDA 510(k) clearance for the TOPICAL COOLING DEV. TCD. #27-999. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Cobe Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 16 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 Cobe Laboratories, Inc. devices

Submission Details

510(k) Number K800717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1980
Decision Date April 16, 1980
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K800717.
COBE HEAT EXCHANGER RESERVOIR MODULE
K812093 · Cobe Laboratories, Inc. · Aug 1981
BRONCHEK-SHILEY CARDIAC JACKET & BSC J
K811204 · Shiley, Inc. · May 1981
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · Shiley, Inc. · Dec 1980
CARDIOPLEGIA DELIVERY SYSTEM
K800377 · 3M Health Care, Sarns · Mar 1980
MINIPRIME HYPOTHERMIC HEAT EXCHANGER
K791430 · Travenol Laboratories, S.A. · Aug 1979
PAD, COOLING #27-999
K781764 · Cobe Laboratories, Inc. · Dec 1978