Cleared Traditional

K946201 - STAND, INFUSION (FDA 510(k) Clearance)

Class I General Hospital device.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 128d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.