NUP · Class II · 21 CFR 880.5045

FDA Product Code NUP: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

The Device Is Intended To Promote Alleviation Of Mild Allergic Symptoms Triggered By The Inhalation Of Various Allergens.

Leading manufacturers include Nasaleze International, Ltd. and Altamira Therapeutics, Inc..

8
Total
8
Cleared
171d
Avg days
2005
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Cream, Nasal, Topical, Mechanical Allergen Particle Barrier Devices (Product Code NUP)

8 devices
1–8 of 8
Cleared Jun 24, 2022
BentrioTM Allergy Blocker
K213114
Altamira Therapeutics, Inc.
Ear, Nose, Throat · 270d
Cleared Mar 26, 2021
AllerBlock Junior
K201734
Nasaleze International, Ltd.
Ear, Nose, Throat · 274d

About Product Code NUP - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code NUP since 2005, with 8 receiving FDA clearance (average review time: 171 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.