Cleared Traditional

K842829 - HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS (FDA 510(k) Clearance)

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

K842829 · North American Instrument Corp. · Cardiovascular device
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Oct 1984
Decision
90d
Days
Class 2
Risk

K842829 is an FDA 510(k) clearance for the HIGH PRESSURE, 1 & 3 WAY STERILE DISPOS. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by North American Instrument Corp. (Hudson Falls, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 90 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 North American Instrument Corp. devices

Submission Details

510(k) Number K842829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date October 18, 1984
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.