Cleared Traditional

K862919 - TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER

K862919 is an FDA 510(k) clearance for TRANSPIRATOR(TM) MT-1000 PERSONAL HUMID..., manufactured by Transpirator Technologics, Inc.. The device is a Class 1 Anesthesiology device with product code KFZ cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K862919 · Transpirator Technologics, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K862919

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
42d faster than avg
Panel avg: 140d · This submission: 98d
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.

K862919 · TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
Download PDF Transpirator Technolo…