Cleared Traditional

K890685 - BARD UMBILICAL VESSEL CATHETER

K890685 is an FDA 510(k) clearance for BARD UMBILICAL VESSEL CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 General Hospital device with product code FOS cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K890685 · C.R. Bard, Inc. · General Hospital
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Feb 1989
Decision
19d
Days
Class 2
Risk

K890685 is an FDA 510(k) clearance for the BARD UMBILICAL VESSEL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tewksbury, US). The FDA issued a Cleared decision on February 28, 1989 after a review of 19 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K890685

510(k) Number K890685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1989
Decision Date February 28, 1989
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 K890685.
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
K921374 · Vygon Corp. · Oct 1992
GESCO UMBILI-CATH
K911607 · Gesco Intl., Inc. · Jun 1991
GESCO DUAL LUMEN UMBILICATH II-DL
K896041 · Gesco Intl., Inc. · Apr 1990
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985
XRO UMBILICAL CATHETER-CODE 270
K851005 · Vygon Corp. · May 1985
INTRAVASCULAR CATHETER
K831988 · C.R. Bard, Inc. · Nov 1983