Cleared Traditional

K221892 - VISIONAIR (FDA 510(k) Clearance)

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

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

Submitted by Pacificmd Biotech, LLC (Henderson, US). The FDA issued a Cleared decision on October 5, 2022, 98 days after receiving the submission on June 29, 2022.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 868.1800.

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

Device Classification

Product Code BXQ - Rhinoanemometer (measurement Of Nasal Decongestion)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 868.1800