Cleared Traditional

K864753 - FREE SPIRIT(TM) I.V. STAND

K864753 is an FDA 510(k) clearance for FREE SPIRIT(TM) I.V. STAND, manufactured by Demstar Corp.. The device is a Class 1 General Hospital device with product code FOX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K864753 · Demstar Corp. · General Hospital
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Jan 1987
Decision
46d
Days
Class 1
Risk

K864753 is an FDA 510(k) clearance for the FREE SPIRIT(TM) I.V. STAND. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Demstar Corp. (Minneapolis, US). The FDA issued a Cleared decision on January 20, 1987 after a review of 46 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 Demstar Corp. devices

FDA 510(k) Submission Details - K864753

510(k) Number K864753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1986
Decision Date January 20, 1987
Days to Decision 46 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
83d faster than avg
Panel avg: 129d · This submission: 46d
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 11
Devices cleared under the same product code (FOX) and FDA review panel - the closest regulatory comparables to K864753.
HANGER, INTRAVENOUS/I.V. BAG HANGER OR HOLDER
K883133 · Ferguson Medical · Nov 1988
POLE, INTRAVENOUS
K880537 · Ferguson Medical · Apr 1988
TRACK AND CARRIER, INTRAVENOUS
K880538 · Ferguson Medical · Feb 1988
IMPACT 901 SERIES PORT-A-WALL
K850671 · Impact Instrumentation, Inc. · Mar 1985
CATHETER, SURFLO, I.V.
K770422 · Terumo America, Inc. · Mar 1977