510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K134003Substantially Equivalent

Rhinix Nasal Filter

Rhinix ApS, Egaa, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K134003 is the FDA 510(k) clearance record for RHINIX NASAL FILTER, a class II device, cleared for Rhinix Aps on under FDA product code NUP (Cream, Nasal, Topical, Mechanical Allergen Particle Barrier). FDA's definition for product code NUP reads: "THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS". FDA records list one 510(k) clearance for Rhinix Aps. As of , FDA records show no recalls naming K134003.

Clearance record

Decision date
Received
(251 days to decision)
Product code
NUP Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
Regulation
21 CFR 880.5045
Device class
Class II
Review panel
General Hospital
Applicant
Rhinix Aps Skagenvej 21, Egaa, DK
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUP

Trailing 12 months

FDA records hold no clearances under product code NUP in the trailing twelve months.

FDA records show no clearances under product code NUP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NUP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260