Cleared Traditional

K823845 - PORT-LOCK

K823845 is the FDA 510(k) clearance for PORT-LOCK by Norfolk Medical Products, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K823845 · Norfolk Medical Products, Inc. · General Hospital
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Mar 1983
Decision
70d
Days
Class 2
Risk

K823845 is an FDA 510(k) clearance for the PORT-LOCK. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Norfolk Medical Products, Inc. (Walker, US). The FDA issued a Cleared decision on March 1, 1983 after a review of 70 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - the FDA general hospital device 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 Norfolk Medical Products, Inc. devices

Submission Details

510(k) Number K823845 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date March 01, 1983
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 General Hospital devices follow this clearance model.

Regulatory Peers - FPA Set, Administration, Intravascular

All 417
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K823845.
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K830891 · Valleylab, Inc. · Apr 1983
MINILOOP I.V. CONNECTORS & ADAPTOR
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MINILOOP DISPOS. IV CONNECTORS ADAPT.
K830178 · Medex, Inc. · Feb 1983
ACCUSET ADMINISTRATION SET
K823346 · Imed Corp. · Nov 1982