Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
The Nasal Topical Mechanical Allergen Particle Barrier Cream is a device intended to promote alleviation of mild allergic symptoms triggered by inhalation of various allergens by forming a physical barrier at the nasal lining to trap airborne particles before they can cause an allergic response. It is an FDA Class 2 device regulated under 21 CFR 880.5045 in the General Hospital specialty, reviewed by the Ear, Nose, and Throat panel, with product code NUP, requiring 510(k) clearance. It is not an implant and does not carry life-sustaining support designation.
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Basic Information
- Product Code
- NUP
- Device Class
- FDA class 2
- Regulation Number
- 880.5045
- Medical Specialty
- General Hospital
- Review Panel
- EN
- Submission Type
- 1
Device Characteristics
Definition
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K213114 | BentrioTM Allergy Blocker | Jun 24, 2022 | Substantially Equivalent | Altamira Therapeutics, Inc. |
| K201734 | AllerBlock Junior | Mar 26, 2021 | Substantially Equivalent | Nasaleze International, Ltd. |
| K170848 | Alzair Allergy Blocker | Jun 14, 2017 | Substantially Equivalent | Nasaleze International, Ltd. |
| K134003 | RHINIX NASAL FILTER | Sep 04, 2014 | Substantially Equivalent | Rhinix Aps |
| K132520 | NASAL EASE ALLERGY BLOCKER | Dec 31, 2013 | Substantially Equivalent | Hi-Tech Pharmacal, Inc. |
| K120894 | HAYMAX | May 17, 2012 | Substantially Equivalent | Haymax Limited |
| K053625 | NASALGUARD | Feb 22, 2006 | Substantially Equivalent | Trutek Corp |
| K042610 | DR. THEISS ALERGOL POLLEN BLOCKER CREAM | May 16, 2005 | Substantially Equivalent | Dr. Theiss Naturwaren GmbH |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.