Cleared Traditional

K941814 - ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER

K941814 is an FDA 510(k) clearance for ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER, manufactured by Sherwood Medical Co.. The device is a Class 2 General Hospital device with product code FOS cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K941814 · Sherwood Medical Co. · General Hospital
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Sep 1994
Decision
171d
Days
Class 2
Risk

K941814 is an FDA 510(k) clearance for the ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Sherwood Medical Co. (St. Louis, US). The FDA issued a Cleared decision on September 30, 1994 after a review of 171 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 Sherwood Medical Co. devices

FDA 510(k) Submission Details - K941814

510(k) Number K941814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1994
Decision Date September 30, 1994
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 129d · This submission: 171d
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 26
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K941814.
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY
K951737 · Sherwood Medical Co. · Sep 1995
CENTURION UMBILICAL CATHETER
K942353 · Tri-State Hospital Supply Corp. · Aug 1995
IV CATHETER AND OBTURATOR
K941429 · Becton Dickinson Vascular Access, Inc. · Jan 1995
ARGYLE NEO-SERT
K942564 · Sherwood Medical Co. · Aug 1994
UMBILI-CATH
K940870 · Gesco Intl., Inc. · Aug 1994
UMBILI-CATH-S
K940953 · Gesco Intl., Inc. · Aug 1994