K134003 is an FDA 510(k) clearance for the RHINIX NASAL FILTER. Classified as Cream, Nasal, Topical, Mechanical Allergen Particle Barrier (product code NUP), Class II - Special Controls.
Submitted by Rhinix Aps (Egaa, DK). The FDA issued a Cleared decision on September 4, 2014 after a review of 251 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.
NCT01699165
Completed
Interventional
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis (Hay Fever)
Efficacy and Safety of Nasal Filters on Seasonal Allergic Rhinitis in a Double-blinded Randomized Placebo-controlled Crossover Pilot Study
| Condition studied |
Rhinitis, Allergic, Seasonal |
| Study design |
Crossover |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Torben Sigsgaard, Professor |
| Sponsor |
University of Aarhus
|
Started 2012-12-01
→
Primary completion 2013-02-01
Primary outcome
Effect of active nasal filters compared to placebo filters in the same patient group as measured by difference in maximum Total Nasal Symptom Score
Secondary outcome
Effect of active nasal filters compared to placebo filters as measured by acoustic rhinometry
Study completed - no results published.
This trial concluded in 2013 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov