Cleared Traditional

K961894 - MDI TUTOR (FDA 510(k) Clearance)

Class I Anesthesiology device.

K961894 · Mdi Tutor, Inc. · Anesthesiology device
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Aug 1996
Decision
90d
Days
Class 1
Risk

K961894 is an FDA 510(k) clearance for the MDI TUTOR. Classified as Nebulizer, Medicinal, Non-ventilatory (atomizer) (product code CCQ), Class I - General Controls.

Submitted by Mdi Tutor, Inc. (North Attleboro, US). The FDA issued a Cleared decision on August 14, 1996 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5640 - the FDA anesthesiology and respiratory 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 Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Mdi Tutor, Inc. devices

Submission Details

510(k) Number K961894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1996
Decision Date August 14, 1996
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 139d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CCQ Nebulizer, Medicinal, Non-ventilatory (atomizer)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5640
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.