Cleared Traditional

XRO UMBILICAL CATHETER-CODE 270 (K851005) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851005 · Vygon Corp. · General Hospital
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May 1985
Decision
70d
Days
Class 2
Risk

K851005 is an FDA 510(k) clearance for the XRO UMBILICAL CATHETER-CODE 270. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Vygon Corp. (East Rutherford, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 70 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 Vygon Corp. devices

Submission Details

510(k) Number K851005 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1985
Decision Date May 21, 1985
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
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 10
Devices cleared under the same product code (FOS) and FDA review panel - the closest regulatory comparables to K851005.
ARGYLE NEO-SERT
K942564 · Sherwood Medical Co. · Aug 1994
BARD UMBILICAL VESSEL CATHETER
K890685 · C.R. Bard, Inc. · Feb 1989
ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
K850884 · Sherwood Medical Co. · Oct 1985
INTRAVASCULAR CATHETER
K831988 · C.R. Bard, Inc. · Nov 1983
CATHETER, UMBILICAL, VICRA
K771891 · Travenol Laboratories, S.A. · Nov 1977