Cleared Traditional

K940953 - UMBILI-CATH-S

K940953 is the FDA 510(k) clearance for UMBILI-CATH-S by Gesco Intl., Inc.. It is a Class 2 General Hospital device (product code FOS) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K940953 · Gesco Intl., Inc. · General Hospital
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Aug 1994
Decision
154d
Days
Class 2
Risk

K940953 is an FDA 510(k) clearance for the UMBILI-CATH-S. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Gesco Intl., Inc. (San Antonio, US). The FDA issued a Cleared decision on August 2, 1994 after a review of 154 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 Gesco Intl., Inc. devices

Submission Details

510(k) Number K940953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1994
Decision Date August 02, 1994
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
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 K940953.
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY
K951737 · Sherwood Medical Co. · Sep 1995
ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER
K941814 · Sherwood Medical Co. · Sep 1994
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