Cleared Traditional

K070467 - HEALTH MASK (FDA 510(k) Clearance)

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070467 · Polar Wrap, LLC · Anesthesiology device
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Optimized for regulatory review, auditing and printing
Apr 2007
Decision
60d
Days
Class 2
Risk

K070467 is an FDA 510(k) clearance for the HEALTH MASK. Classified as Humidifier, Respiratory, Mask (direct Patient Interface) (product code OBN), Class II - Special Controls.

Submitted by Polar Wrap, LLC (Bonita Springs, US). The FDA issued a Cleared decision on April 17, 2007 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Polar Wrap, LLC devices

Submission Details

510(k) Number K070467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2007
Decision Date April 17, 2007
Days to Decision 60 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 139d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OBN Humidifier, Respiratory, Mask (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
Definition Intended To Moderate Blood Pressure In Hypertensive Patients When They Are Exposed To The Cold. The Mask Attenuates (moderates) The Physiological Response, Increases In Blood Pressure, Associated With Cold Exposure, By Warming The Inhaled Air During Cold Exposure For Individuals With Hypertension, Medicated Or Non-medicated.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.