Cleared Traditional

K801828 - MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS

K801828 is an FDA 510(k) clearance for MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS, manufactured by Graphic Controls Corp.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K801828 · Graphic Controls Corp. · Cardiovascular device
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Aug 1980
Decision
27d
Days
Class 2
Risk

K801828 is an FDA 510(k) clearance for the MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Graphic Controls Corp. (Mchenry, US). The FDA issued a Cleared decision on August 27, 1980 after a review of 27 days - a notably fast clearance cycle.

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: 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 Graphic Controls Corp. devices

FDA 510(k) Submission Details - K801828

510(k) Number K801828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1980
Decision Date August 27, 1980
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 108
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K801828.
WM. HARVEY OVERPRESSURE SAFETY VALVE
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VYGON STOPCOCKS & RAMPS(MANIFOLDS)
K813141 · Exco, Inc. · Nov 1981
DISPOSABLE QUICK RELEASE PERFUSION ADAP
K802544 · Texas Medical Products, Inc. · Jan 1981
CORONARY PERFUSION CONNECTOR PLUG
K801399 · Texas Medical Products, Inc. · Jun 1980
QUICKIE PRIME CARDIOP. BYPASS PERF. INTR
K801402 · Texas Medical Products, Inc. · Jun 1980
DISPOSABLE PARALLEL Y CONNECTORS
K801404 · Texas Medical Products, Inc. · Jun 1980