Cleared Traditional

K946201 - STAND, INFUSION

K946201 is an FDA 510(k) clearance for STAND, manufactured by Medical Specialties, Inc.. The device is a Class 1 General Hospital device with product code FOX cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K946201 · Medical Specialties, Inc. · General Hospital
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Apr 1995
Decision
118d
Days
Class 1
Risk

K946201 is an FDA 510(k) clearance for the STAND, INFUSION. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Medical Specialties, Inc. (South Easton, US). The FDA issued a Cleared decision on April 18, 1995 after a review of 118 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medical Specialties, Inc. devices

FDA 510(k) Submission Details - K946201

510(k) Number K946201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1994
Decision Date April 18, 1995
Days to Decision 118 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
11d faster than avg
Panel avg: 129d · This submission: 118d
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 K946201.
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
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