Cleared Traditional

K852283 - THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE (FDA 510(k) Clearance)

Class I Anesthesiology device.

K852283 · Thermix, Inc. · Anesthesiology device
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Jul 1985
Decision
62d
Days
Class 1
Risk

K852283 is an FDA 510(k) clearance for the THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINE. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Thermix, Inc. (Chicago, US). The FDA issued a Cleared decision on July 30, 1985 after a review of 62 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 Thermix, Inc. devices

Submission Details

510(k) Number K852283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1985
Decision Date July 30, 1985
Days to Decision 62 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 139d · This submission: 62d
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.