Cleared Traditional

K802545 - CARDIOPLEGIC SETS

K802545 is the FDA 510(k) clearance for CARDIOPLEGIC SETS by Texas Medical Products, Inc.. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K802545 · Texas Medical Products, Inc. · Cardiovascular device
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Jan 1981
Decision
93d
Days
Class 2
Risk

K802545 is an FDA 510(k) clearance for the CARDIOPLEGIC SETS. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Texas Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1981 after a review of 93 days - within the typical 510(k) review window.

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: 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 Texas Medical Products, Inc. devices

Submission Details

510(k) Number K802545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1980
Decision Date January 16, 1981
Days to Decision 93 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 125d · This submission: 93d
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 78
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K802545.
D6ZO DISPOSABLE HEAT EXCHANGER
K813264 · Electromedics, Inc. · Jul 1982
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 COOLING SYST. CCAS-2
K802848 · Bentley Laboratories, Inc. · Dec 1980
TOPICAL COOLING DEV. TCD. #27-999
K800717 · Cobe Laboratories, Inc. · Apr 1980