Cleared Traditional

K890685 - BARD UMBILICAL VESSEL CATHETER

K890685 is the FDA 510(k) clearance for BARD UMBILICAL VESSEL CATHETER by C.R. Bard, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

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 K890685.
ARGYLE NEO-SERT
K942564 · Sherwood Medical Co. · Aug 1994
VYGON POLYURETHANE VENOUS/ARTERIAL XRO UMBIL. CATH
K921352 · Vygon Corp. · Oct 1992
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER
K921374 · Vygon Corp. · Oct 1992
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