Cleared Traditional

K942564 - ARGYLE NEO-SERT

K942564 is the FDA 510(k) clearance for ARGYLE NEO-SERT by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code FOS) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K942564 · Sherwood Medical Co. · General Hospital

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Aug 1994

Decision

86d

Days

Class 2

Risk

K942564 is an FDA 510(k) clearance for the ARGYLE NEO-SERT. 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 August 25, 1994 after a review of 86 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 Sherwood Medical Co. devices

Submission Details

510(k) Number	K942564 FDA.gov
FDA Decision	Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received	May 31, 1994
Decision Date	August 25, 1994
Days to Decision	86 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

43d faster than avg

Panel avg: 129d · This submission: 86d

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 K942564.

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

VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH

K921352 · Vygon Corp. · Oct 1992

VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER

K921374 · Vygon Corp. · Oct 1992

BARD UMBILICAL VESSEL CATHETER

K890685 · C.R. Bard, Inc. · Feb 1989

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K942564

Sherwood Medical Co.

St. Louis, MO · US

DENNIS POZZO

Regulatory profile

191 submissions 177 cleared

93% clearance rate · Active in General Hospital

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Sourced from FDA 510(k) public files . Updated monthly.

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