Cleared Traditional

NEOMED SINGLE LUMEN UMBILICAL CATHETER (K073596) - FDA 510(k) Clearance

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

K073596 · Neomed, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
63d
Days
Class 2
Risk

K073596 is an FDA 510(k) clearance for the NEOMED SINGLE LUMEN UMBILICAL CATHETER. Classified as Catheter, Umbilical Artery (product code FOS), Class II - Special Controls.

Submitted by Neomed, Inc. (Swanee, US). The FDA issued a Cleared decision on February 22, 2008 after a review of 63 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 Neomed, Inc. devices

Submission Details

510(k) Number K073596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2007
Decision Date February 22, 2008
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
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.