Cleared Traditional

K840118 - RHINOTHERM

K840118 is an FDA 510(k) clearance for RHINOTHERM, manufactured by Ascot Pharmaceuticals, Inc.. The device is a Class 1 Anesthesiology device with product code KFZ cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K840118 · Ascot Pharmaceuticals, Inc. · Anesthesiology device
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Apr 1984
Decision
93d
Days
Class 1
Risk

K840118 is an FDA 510(k) clearance for the RHINOTHERM. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Ascot Pharmaceuticals, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1984 after a review of 93 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.

FDA 510(k) Submission Details - K840118

510(k) Number K840118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 1984
Decision Date April 13, 1984
Days to Decision 93 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 140d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

KFZ Device Classification - Class 1, General Controls

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.

K840118 · RHINOTHERM
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