Cleared Traditional

K213114 - BentrioTM Allergy Blocker

K213114 is an FDA 510(k) clearance for BentrioTM Allergy Blocker, manufactured by Altamira Therapeutics, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code NUP cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K213114 · Altamira Therapeutics, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
270d
Days
Class 2
Risk

K213114 is an FDA 510(k) clearance for the BentrioTM Allergy Blocker. Classified as Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (product code NUP), Class II - Special Controls.

Submitted by Altamira Therapeutics, Inc. (Dover, US). The FDA issued a Cleared decision on June 24, 2022 after a review of 270 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 880.5045 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K213114

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 90d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NUP Device Classification - Class 2, Special Controls

Product Code NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Consultant

DuVal & Associates, P.A.
Patrick Johnson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

All 7
Devices cleared under the same product code (NUP) and FDA review panel - the closest regulatory comparables to K213114.
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