Cleared Traditional

K932498 - MOBILE CARE IV STAND

K932498 is an FDA 510(k) clearance for MOBILE CARE IV STAND, manufactured by Mobile Care, Inc.. The device is a Class 1 General Hospital device with product code FOX cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K932498 · Mobile Care, Inc. · General Hospital
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Oct 1993
Decision
156d
Days
Class 1
Risk

K932498 is an FDA 510(k) clearance for the MOBILE CARE IV STAND. Classified as Stand, Infusion (product code FOX), Class I - General Controls.

Submitted by Mobile Care, Inc. (Chicago, US). The FDA issued a Cleared decision on October 27, 1993 after a review of 156 days - an extended review 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: 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 Mobile Care, Inc. devices

FDA 510(k) Submission Details - K932498

510(k) Number K932498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1993
Decision Date October 27, 1993
Days to Decision 156 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
27d slower than avg
Panel avg: 129d · This submission: 156d
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 K932498.
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