BXQ · Class II · 21 CFR 868.1800

FDA Product Code BXQ: Rhinoanemometer (measurement Of Nasal Decongestion)

Leading manufacturers include Pacificmd Biotech, LLC, Jedmed Instrument Co. and Life-Tech Intl., Inc..

12
Total
12
Cleared
197d
Avg days
1984
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Rhinoanemometer (measurement Of Nasal Decongestion) Devices (Product Code BXQ)

12 devices
1–12 of 12
Cleared Oct 05, 2022
VISIONAIR
K221892
Pacificmd Biotech, LLC
Ear, Nose, Throat · 98d
Cleared Aug 06, 1990
MERCURY RHINOMANOMETER
K902120
Life-Tech Intl., Inc.
Anesthesiology · 87d
Cleared Apr 16, 1990
RHINOMANOMETER
K896263
Jedmed Instrument Co.
Anesthesiology · 167d

About Product Code BXQ - Regulatory Context

510(k) Submission Activity

12 total 510(k) submissions under product code BXQ since 1984, with 12 receiving FDA clearance (average review time: 197 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.