Cleared Traditional

K880538 - TRACK AND CARRIER, INTRAVENOUS (FDA 510(k) Clearance)

Class I General Hospital device.

K880538 · Ferguson Medical · General Hospital
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Feb 1988
Decision
10d
Days
Class 1
Risk

K880538 is an FDA 510(k) clearance for the TRACK AND CARRIER, INTRAVENOUS. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Ferguson Medical (Chico, US). The FDA issued a Cleared decision on February 19, 1988 after a review of 10 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6990 - 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 Ferguson Medical devices

Submission Details

510(k) Number K880538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 1988
Decision Date February 19, 1988
Days to Decision 10 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
118d faster than avg
Panel avg: 128d · This submission: 10d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOX Stand, Infusion
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6990
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.