Cleared Traditional

K842858 - FLUID ADMINISTRATION LINE W/SPIKE 14-923

K842858 is an FDA 510(k) clearance for FLUID ADMINISTRATION LINE W/SPIKE 14-923, manufactured by Norton Performance Plastics Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K842858 · Norton Performance Plastics Corp. · General Hospital
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Sep 1984
Decision
50d
Days
Class 2
Risk

K842858 is an FDA 510(k) clearance for the FLUID ADMINISTRATION LINE W/SPIKE 14-923. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Mchenry, US). The FDA issued a Cleared decision on September 11, 1984 after a review of 50 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 Norton Performance Plastics Corp. devices

FDA 510(k) Submission Details - K842858

510(k) Number K842858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1984
Decision Date September 11, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 784
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K842858.
MINISET VEIN INFUSION SETS
K843631 · Travenol Laboratories, S.A. · Oct 1984
EXTENSION SET W/INJECTION SITE
K842984 · Med Fusion Systems, Inc. · Oct 1984
IVAC C80014 Y SOLUTION ADMIN. SET
K843185 · Y · Sep 1984
T-TYPE IV EXTENSION SET
K843249 · Strato Medical Corp. · Sep 1984
BENT WINGED MINI-VOL INFUSION SET
K842143 · Med Fusion Systems, Inc. · Jul 1984
THREE WAY INFUSION SET
K841882 · Med Fusion Systems, Inc. · Jun 1984