Cleared Traditional

K950116 - THERASTEAM PERSONAL STEAM INHALER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K950116 · Kaz, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Feb 1995
Decision
30d
Days
Class 1
Risk

K950116 is an FDA 510(k) clearance for the THERASTEAM PERSONAL STEAM INHALER. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Kaz, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on February 10, 1995 after a review of 30 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kaz, Inc. devices

Submission Details

510(k) Number K950116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1995
Decision Date February 10, 1995
Days to Decision 30 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
109d faster than avg
Panel avg: 139d · This submission: 30d
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.