Cleared Traditional

UMBILICAL VESSEL CATHETER (K840339) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840339 · Catheter Technology Corp. · General Hospital
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Jul 1984
Decision
182d
Days
Class 2
Risk

K840339 is an FDA 510(k) clearance for the UMBILICAL VESSEL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Catheter Technology Corp. (Mchenry, US). The FDA issued a Cleared decision on July 25, 1984 after a review of 182 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Catheter Technology Corp. devices

Submission Details

510(k) Number K840339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1984
Decision Date July 25, 1984
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOS Catheter, Umbilical Artery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOS Catheter, Umbilical Artery

All 10
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K840339.
ARGYLE NEO-SERT
K942564 · Sherwood Medical Co. · Aug 1994
BARD UMBILICAL VESSEL CATHETER
K890685 · C.R. Bard, Inc. · Feb 1989
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985
INTRAVASCULAR CATHETER
K831988 · C.R. Bard, Inc. · Nov 1983
CATHETER, UMBILICAL, VICRA
K771891 · Travenol Laboratories, S.A. · Nov 1977