Cleared Traditional

K850711 - INHALATION THERAPY NEBULIZER DEVICE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K850711 · Med USA · Anesthesiology device
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Jun 1985
Decision
103d
Days
Class 1
Risk

K850711 is an FDA 510(k) clearance for the INHALATION THERAPY NEBULIZER DEVICE. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Med USA (Waltham, US). The FDA issued a Cleared decision on June 5, 1985 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5460 - 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.

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Submission Details

510(k) Number K850711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1985
Decision Date June 05, 1985
Days to Decision 103 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 139d · This submission: 103d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KFZ Humidifier, Non-direct Patient Interface (home-use)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5460
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.