Cleared Traditional

K802544 - DISPOSABLE QUICK RELEASE PERFUSION ADAP

K802544 is an FDA 510(k) clearance for DISPOSABLE QUICK RELEASE PERFUSION ADAP, manufactured by Texas Medical Products, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K802544 · Texas Medical Products, Inc. · Cardiovascular device
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Jan 1981
Decision
93d
Days
Class 2
Risk

K802544 is an FDA 510(k) clearance for the DISPOSABLE QUICK RELEASE PERFUSION ADAP. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), 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 870.4290 - 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

FDA 510(k) Submission Details - K802544

510(k) Number K802544 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
Combination Product No
PCCP Authorized No
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.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 103
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K802544.
NORTON MANIFOLD
K820864 · Norton Performance Plastics Corp. · Apr 1982
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · C.R. Bard, Inc. · Mar 1982
VYGON STOPCOCKS & RAMPS(MANIFOLDS)
K813141 · Exco, Inc. · Nov 1981
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828 · Graphic Controls Corp. · Aug 1980
CORONARY PERFUSION CONNECTOR PLUG
K801399 · Texas Medical Products, Inc. · Jun 1980
QUICKIE PRIME CARDIOP. BYPASS PERF. INTR
K801402 · Texas Medical Products, Inc. · Jun 1980