Cleared Traditional

K960027 - HIGH VOLUME I.V. & IRRIGATION TOWER

K960027 is an FDA 510(k) clearance for HIGH VOLUME I.V. & IRRIGATION TOWER, manufactured by Allen Medical Systems, Inc.. The device is a Class 1 General Hospital device with product code FOX cleared through the Traditional 510(k) pathway after a 70-day FDA review.

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

FDA 510(k) Submission Details - K960027

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

FOX Device Classification - Class 1, General Controls

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.

Regulatory Peers - FOX Stand, Infusion

All 10
Devices cleared under the same product code (FOX) and FDA review panel - the closest regulatory comparables to K960027.
IV STANDS
K980336 · Clinton Industries, Inc. · Apr 1998
MEDRAD CONTRAST HOLDER
K964782 · Medrad, Inc. · Feb 1997
PORT-A-POLE
K961470 · Prins Medical Ind., Inc. · Jul 1996
STAND, INFUSION
K946201 · Medical Specialties, Inc. · Apr 1995
FLEXSYS MOBILEMATE EQUIPMENT STAND
K944580 · Hill-Rom, Inc. · Mar 1995
HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER
K883133 · Ferguson Medical · Nov 1988