Cleared Traditional

K790604 - CUSTOM TUBING SETS

K790604 is the FDA 510(k) clearance for CUSTOM TUBING SETS by Norton Performance Plastics Corp.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K790604 · Norton Performance Plastics Corp. · General Hospital
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May 1979
Decision
46d
Days
Class 2
Risk

K790604 is an FDA 510(k) clearance for the CUSTOM TUBING SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Norton Performance Plastics Corp. (Walker, US). The FDA issued a Cleared decision on May 4, 1979 after a review of 46 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

Submission Details

510(k) Number K790604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1979
Decision Date May 04, 1979
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 452
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K790604.
CONTINU-FLO ADMIN. SET CODE 2C/200
K792538 · Travenol Laboratories, S.A. · Dec 1979
IV EXTENSION SET SL
K791930 · Abbott Laboratories · Oct 1979
INTRAVASCULAR ADMINISTRATION SET
K790582 · Y · May 1979
T-CONNECTOR
K790408 · Medex, Inc. · Apr 1979
EPIC D215
K790574 · National Patent Development Corp. · Apr 1979
IV ADMINISTRATION SET WITH BACKCHECK
K790062 · National Patent Development Corp. · Apr 1979