Cleared Traditional

K850884 - ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER

K850884 is an FDA 510(k) clearance for ARGYLE POLYURETHANE UMBILICAL VESSEL CA..., 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 227-day FDA review.

K850884 · Sherwood Medical Co. · General Hospital
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Oct 1985
Decision
227d
Days
Class 2
Risk

K850884 is an FDA 510(k) clearance for the ARGYLE POLYURETHANE 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 October 17, 1985 after a review of 227 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 - K850884

510(k) Number K850884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1985
Decision Date October 17, 1985
Days to Decision 227 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 129d · This submission: 227d
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 K850884.
GESCO UMBILI-CATH
K911607 · Gesco Intl., Inc. · Jun 1991
GESCO DUAL LUMEN UMBILICATH II-DL
K896041 · Gesco Intl., Inc. · Apr 1990
BARD UMBILICAL VESSEL CATHETER
K890685 · C.R. Bard, Inc. · Feb 1989
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