Cleared Traditional

K201167 - AireHealth NebulizerTM

K201167 is the FDA 510(k) clearance for AireHealth NebulizerTM by Airehealth, Inc.. It is a Class 2 Anesthesiology device (product code CAF) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K201167 · Airehealth, Inc. · Anesthesiology device
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Dec 2020
Decision
216d
Days
Class 2
Risk

K201167 is an FDA 510(k) clearance for the AireHealth NebulizerTM. Classified as Nebulizer (direct Patient Interface) (product code CAF), Class II - Special Controls.

Submitted by Airehealth, Inc. (Orlando, US). The FDA issued a Cleared decision on December 3, 2020 after a review of 216 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5630 - 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 Airehealth, Inc. devices

Submission Details

510(k) Number K201167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2020
Decision Date December 03, 2020
Days to Decision 216 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 140d · This submission: 216d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAF Nebulizer (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5630
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.

Regulatory Consultant

Regulatory and Quality Solutions, LLC
Jessica Czamanski

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - CAF Nebulizer (direct Patient Interface)

All 134
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