K213114 is an FDA 510(k) clearance for the BentrioTM Allergy Blocker. This device is classified as a Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (Class II - Special Controls, product code NUP).
Submitted by Altamira Therapeutics, Inc. (Dover, US). The FDA issued a Cleared decision on June 24, 2022, 270 days after receiving the submission on September 27, 2021.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 880.5045. The Device Is Intended To Promote Alleviation Of Mild Allergic Symptoms Triggered By The Inhalation Of Various Allergens..
| 510(k) Number | K213114 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 2021 |
| Decision Date | June 24, 2022 |
| Days to Decision | 270 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | NUP - Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5045 |
| Definition | The Device Is Intended To Promote Alleviation Of Mild Allergic Symptoms Triggered By The Inhalation Of Various Allergens. |