Cleared Traditional

K201734 - AllerBlock Junior (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K201734 · Nasaleze International, Ltd. · Ear, Nose, Throat device
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Mar 2021
Decision
274d
Days
Class 2
Risk

K201734 is an FDA 510(k) clearance for the AllerBlock Junior. Classified as Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (product code NUP), Class II - Special Controls.

Submitted by Nasaleze International, Ltd. (Douglas, IM). The FDA issued a Cleared decision on March 26, 2021 after a review of 274 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.

View all Nasaleze International, Ltd. devices

Submission Details

510(k) Number K201734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2020
Decision Date March 26, 2021
Days to Decision 274 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
185d slower than avg
Panel avg: 89d · This submission: 274d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.