Cleared Traditional

K221892 - VISIONAIR (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221892 · Pacificmd Biotech, LLC · Ear, Nose, Throat device
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Oct 2022
Decision
98d
Days
Class 2
Risk

K221892 is an FDA 510(k) clearance for the VISIONAIR. Classified as Rhinoanemometer (measurement Of Nasal Decongestion) (product code BXQ), Class II - Special Controls.

Submitted by Pacificmd Biotech, LLC (Henderson, US). The FDA issued a Cleared decision on October 5, 2022 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 868.1800 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Pacificmd Biotech, LLC devices

Submission Details

510(k) Number K221892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2022
Decision Date October 05, 2022
Days to Decision 98 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 89d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code BXQ Rhinoanemometer (measurement Of Nasal Decongestion)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1800
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

Canyon Labs
David M. Locke

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.