Cleared Traditional

HIGH VOLUME I.V. & IRRIGATION TOWER (K960027) - FDA 510(k) Clearance

Class I General Hospital device.

K960027 · Allen Medical Systems, Inc. · General Hospital
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Mar 1996
Decision
70d
Days
Class 1
Risk

K960027 is an FDA 510(k) clearance for the HIGH VOLUME I.V. & IRRIGATION TOWER. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Allen Medical Systems, Inc. (Bedford Heights, US). The FDA issued a Cleared decision on March 12, 1996 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 880.6990 - 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 Allen Medical Systems, Inc. devices

Submission Details

510(k) Number K960027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1996
Decision Date March 12, 1996
Days to Decision 70 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
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.

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.