510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221892Substantially Equivalent

Visionair

Pacificmd Biotech, LLC, Henderson NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221892 is the FDA 510(k) clearance record for VISIONAIR, a class II device, cleared for Pacificmd Biotech, LLC on under FDA product code BXQ (Rhinoanemometer (Measurement Of Nasal Decongestion)). FDA records list one 510(k) clearance for Pacificmd Biotech, LLC. As of , FDA records show no recalls naming K221892.

Clearance record

Decision date
Received
(98 days to decision)
Product code
BXQ Rhinoanemometer (Measurement Of Nasal Decongestion)
Regulation
21 CFR 868.1800
Device class
Class II
Review panel
Anesthesiology
Applicant
Pacificmd Biotech, LLC 3195 Saint Rose Pkwy., Suite 210, Henderson NV
510(k) summary
Summary PDF
Third party review
No

Clearances, product code BXQ

Trailing 12 months

FDA records hold no clearances under product code BXQ in the trailing twelve months.

FDA records show no clearances under product code BXQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BXQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260