Cleared Traditional

K954300 - ARGYLE NEO-SERT HYDROPHILIC POLYURETHAN...

K954300 is the FDA 510(k) clearance for ARGYLE NEO-SERT HYDROPHILIC POLYURETHAN... by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FOS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K954300 · Sherwood Medical Co. · General Hospital
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Dec 1995
Decision
90d
Days
Class 2
Risk

K954300 is an FDA 510(k) clearance for the ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION .... 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 December 13, 1995 after a review of 90 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K954300 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1995
Decision Date December 13, 1995
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 13
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K954300.
Umbilical Vessels Catheter
K201697 · Haolang Medical USA Corporation · May 2021
ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER
K951738 · Sherwood Medical Co. · Sep 1995
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
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
K921352 · Vygon Corp. · Oct 1992