Cleared Traditional

K915603 - VIROTHERM HUMIDIFIER

K915603 is an FDA 510(k) clearance for VIROTHERM HUMIDIFIER, manufactured by Virotherm Laboratory. The device is a Class 1 Anesthesiology device with product code KFZ cleared through the Traditional 510(k) pathway after a 311-day FDA review.

K915603 · Virotherm Laboratory · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
311d
Days
Class 1
Risk

K915603 is an FDA 510(k) clearance for the VIROTHERM HUMIDIFIER. Classified as Humidifier, Non-direct Patient Interface (home-use) (product code KFZ), Class I - General Controls.

Submitted by Virotherm Laboratory (Saratoga, US). The FDA issued a Cleared decision on October 22, 1992 after a review of 311 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K915603

510(k) Number K915603 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1991
Decision Date October 22, 1992
Days to Decision 311 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 140d · This submission: 311d
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.