Cleared Traditional

K894734 - RHINOTHERM ULTRA 2 (FDA 510(k) Clearance)

Class I Anesthesiology device.

K894734 · Twinmed Products, Inc. · Anesthesiology device
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Feb 1990
Decision
207d
Days
Class 1
Risk

K894734 is an FDA 510(k) clearance for the RHINOTHERM ULTRA 2. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Twinmed Products, Inc. (Santa Monica, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 207 days - an extended review 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: 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 Twinmed Products, Inc. devices

Submission Details

510(k) Number K894734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date February 16, 1990
Days to Decision 207 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d slower than avg
Panel avg: 139d · This submission: 207d
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.