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., Dr. Theiss Naturwaren GmbH and Trutek Corp.
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
Cleared
Jun 24, 2022
BentrioTM Allergy Blocker
Altamira Therapeutics, Inc.
Ear, Nose, Throat
270d
Cleared
Mar 26, 2021
AllerBlock Junior
Nasaleze International, Ltd.
Ear, Nose, Throat
274d
Cleared
Jun 14, 2017
Alzair Allergy Blocker
Nasaleze International, Ltd.
Ear, Nose, Throat
85d
Cleared
Sep 04, 2014
RHINIX NASAL FILTER
Rhinix Aps
Ear, Nose, Throat
251d
Cleared
Dec 31, 2013
NASAL EASE ALLERGY BLOCKER
Hi-Tech Pharmacal, Inc.
Ear, Nose, Throat
141d
Cleared
May 17, 2012
HAYMAX
Haymax Limited
Ear, Nose, Throat
55d
Cleared
Feb 22, 2006
NASALGUARD
Trutek Corp
Ear, Nose, Throat
56d
Cleared
May 16, 2005
DR. THEISS ALERGOL POLLEN BLOCKER CREAM
Dr. Theiss Naturwaren GmbH
Ear, Nose, Throat
234d
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.