Cleared Traditional

K952196 - IV POLE/STAND

K952196 is an FDA 510(k) clearance for IV POLE/STAND, manufactured by Valentine Intl. , Ltd.. The device is a Class 1 General Hospital device with product code FOX cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K952196 · Valentine Intl. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
83d
Days
Class 1
Risk

K952196 is an FDA 510(k) clearance for the IV POLE/STAND. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Valentine Intl. , Ltd. (Taipei, TW). The FDA issued a Cleared decision on July 31, 1995 after a review of 83 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 Valentine Intl. , Ltd. devices

FDA 510(k) Submission Details - K952196

510(k) Number K952196 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date July 31, 1995
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 K952196.
MEDRAD CONTRAST HOLDER
K964782 · Medrad, Inc. · Feb 1997
PORT-A-POLE
K961470 · Prins Medical Ind., Inc. · Jul 1996
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