Cleared Traditional

K790408 - T-CONNECTOR

K790408 is the FDA 510(k) clearance for T-CONNECTOR by Medex, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K790408 · Medex, Inc. · General Hospital
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Apr 1979
Decision
63d
Days
Class 2
Risk

K790408 is an FDA 510(k) clearance for the T-CONNECTOR. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Medex, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 30, 1979 after a review of 63 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 Medex, Inc. devices

Submission Details

510(k) Number K790408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date April 30, 1979
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K790408.
IV EXTENSION SET SL
K791930 · Abbott Laboratories · Oct 1979
INTRAVASCULAR ADMINISTRATION SET
K790582 · Y · May 1979
CUSTOM TUBING SETS
K790604 · Norton Performance Plastics Corp. · May 1979
EPIC D215
K790574 · National Patent Development Corp. · Apr 1979
IV ADMINISTRATION SET WITH BACKCHECK
K790062 · National Patent Development Corp. · Apr 1979
FILTERSET 0.22, I.V. PUMP
K790108 · Imed Corp. · Mar 1979