Cleared Traditional

K900981 - INTRAVENOUS STAND OR IV STAND

K900981 is an FDA 510(k) clearance for INTRAVENOUS STAND OR IV STAND, manufactured by Travl-Med Infusion Device Transport System. The device is a Class 1 General Hospital device with product code FOX cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K900981 · Travl-Med Infusion Device Transport System · General Hospital
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Mar 1990
Decision
25d
Days
Class 1
Risk

K900981 is an FDA 510(k) clearance for the INTRAVENOUS STAND OR IV STAND. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Travl-Med Infusion Device Transport System (Kingston, US). The FDA issued a Cleared decision on March 27, 1990 after a review of 25 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 Travl-Med Infusion Device Transport System devices

FDA 510(k) Submission Details - K900981

510(k) Number K900981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1990
Decision Date March 27, 1990
Days to Decision 25 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
104d faster than avg
Panel avg: 129d · This submission: 25d
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 K900981.
HIGH VOLUME I.V. & IRRIGATION TOWER
K960027 · Allen Medical Systems, Inc. · Mar 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
POLE, INTRAVENOUS
K880537 · Ferguson Medical · Apr 1988
TRACK AND CARRIER, INTRAVENOUS
K880538 · Ferguson Medical · Feb 1988