Cleared Traditional

K820864 - NORTON MANIFOLD

K820864 is the FDA 510(k) clearance for NORTON MANIFOLD by Norton Performance Plastics Corp.. It is a Class 2 Cardiovascular device (product code DTL) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K820864 · Norton Performance Plastics Corp. · Cardiovascular device
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Apr 1982
Decision
17d
Days
Class 2
Risk

K820864 is an FDA 510(k) clearance for the NORTON MANIFOLD. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Walker, US). The FDA issued a Cleared decision on April 15, 1982 after a review of 17 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 Norton Performance Plastics Corp. devices

Submission Details

510(k) Number K820864 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1982
Decision Date April 15, 1982
Days to Decision 17 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
108d faster than avg
Panel avg: 125d · This submission: 17d
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.

Regulatory Peers - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 65
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K820864.
TUBING CONNECTORS EC-2XXX SERIES
K833322 · Gish Biomedical, Inc. · Dec 1983
SCI MED TEMPERATURE MONITORING ADAPTOR
K831260 · Scimed Life Systems, Inc. · Jun 1983
SCI MED TUBING CONNECTORS
K831261 · Scimed Life Systems, Inc. · Jun 1983
WM. HARVEY OVERPRESSURE SAFETY VALVE
K820297 · C.R. Bard, Inc. · Mar 1982
MEDI-TRACE DISP. STOPCOCKS/PHYSIO. PRESS
K801828 · Graphic Controls Corp. · Aug 1980
SAMPLING MANIFOLD H530
K801200 · C.R. Bard, Inc. · Jun 1980