Cleared Traditional

K802414 - UMBILI-CATH CATHETER

K802414 is an FDA 510(k) clearance for UMBILI-CATH CATHETER, manufactured by Int'L Corp.. The device is a Class 2 General Hospital device with product code FOS cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K802414 · Int'L Corp. · General Hospital
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Oct 1980
Decision
20d
Days
Class 2
Risk

K802414 is an FDA 510(k) clearance for the UMBILI-CATH CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Int'L Corp. (Walker, US). The FDA issued a Cleared decision on October 23, 1980 after a review of 20 days - a notably fast clearance 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: 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 Int'L Corp. devices

FDA 510(k) Submission Details - K802414

510(k) Number K802414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1980
Decision Date October 23, 1980
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOS Device Classification - Class 2, Special Controls

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 31
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K802414.
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · Vygon Corp. · May 1985
INTRAVASCULAR CATHETER
K831988 · C.R. Bard, Inc. · Nov 1983
CATHETER, UMBILICAR ARTERY
K771022 · Axiom Medical, Inc. · Nov 1977
CATHETER, UMBILICAL, VICRA
K771891 · Travenol Laboratories, S.A. · Nov 1977
CATHETER, UMBILICAL ARTERY
K760966 · Sherwood Medical Industries · Jan 1977