Cleared Traditional

K862919 - TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER (FDA 510(k) Clearance)

Class I Anesthesiology device.

K862919 · Transpirator Technologics, Inc. · Anesthesiology device
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Nov 1986
Decision
98d
Days
Class 1
Risk

K862919 is an FDA 510(k) clearance for the TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Transpirator Technologics, Inc. (Somerset, US). The FDA issued a Cleared decision on November 7, 1986 after a review of 98 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.

View all Transpirator Technologics, Inc. devices

Submission Details

510(k) Number K862919 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1986
Decision Date November 07, 1986
Days to Decision 98 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 139d · This submission: 98d
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.