Cleared Traditional

HAYMAX (K120894) - FDA 510(k) Clearance

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

K120894 · Haymax Limited · Ear, Nose, Throat device
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May 2012
Decision
55d
Days
Class 2
Risk

K120894 is an FDA 510(k) clearance for the HAYMAX. Classified as Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (product code NUP), Class II - Special Controls.

Submitted by Haymax Limited (Ampthill, Bedfordshire, GB). The FDA issued a Cleared decision on May 17, 2012 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Haymax Limited devices

Submission Details

510(k) Number K120894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 2012
Decision Date May 17, 2012
Days to Decision 55 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 89d · This submission: 55d
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.