FDA product code NUP: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
NUP is the FDA product code for cream, nasal, topical, mechanical allergen particle barrier. It is a Class II device, regulated under 21 CFR 880.5045 and reviewed by the Ear, Nose and Throat panel. FDA has cleared 8 510(k) submissions under NUP, 1 in the last five years, from 7 different applicants. The average 510(k) review took 171 days (median 188).
Definition
THE DEVICE IS INTENDED TO PROMOTE ALLEVIATION OF MILD ALLERGIC SYMPTOMS TRIGGERED BY THE INHALATION OF VARIOUS ALLERGENS.
Classification
| Field | Value |
|---|---|
| Device name | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Device class | Class II |
| Regulation | 21 CFR 880.5045 |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
510(k) clearances per year for NUP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 85 |
| 2021 | 1 | 274 |
| 2022 | 1 | 270 |
Compare with all 510(k) review times · Search every NUP clearance
Top NUP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nasaleze International, Ltd. | 2 | 2021-03-26 |
| Altamira Therapeutics, Inc. | 1 | 2022-06-24 |
| Rhinix Aps | 1 | 2014-09-04 |
| Hi-Tech Pharmacal, Inc. | 1 | 2013-12-31 |
| Haymax Limited | 1 | 2012-05-17 |
2 more applicants have NUP clearances. See the full list in Caduvo.
Most recent NUP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K213114 | Altamira Therapeutics, Inc. | BentrioTM Allergy Blocker | 2022-06-24 | 270 |
| K201734 | Nasaleze International, Ltd. | AllerBlock Junior | 2021-03-26 | 274 |
| K170848 | Nasaleze International, Ltd. | Alzair Allergy Blocker | 2017-06-14 | 85 |
| K134003 | Rhinix Aps | RHINIX NASAL FILTER | 2014-09-04 | 251 |
| K132520 | Hi-Tech Pharmacal, Inc. | NASAL EASE ALLERGY BLOCKER | 2013-12-31 | 141 |
Recalls for NUP devices
openFDA lists no recalls for product code NUP.
Frequently asked questions
What is FDA product code NUP?
NUP is the FDA product code for cream, nasal, topical, mechanical allergen particle barrier. It is a Class II device, regulated under 21 CFR 880.5045 and reviewed by the Ear, Nose and Throat panel.
What device class is NUP?
Class II, regulation 21 CFR 880.5045. Typical premarket route: 510(k).
How long does a 510(k) take for product code NUP?
Across 8 cleared submissions the average was 171 days from receipt to decision (median 188).
Which companies have the most NUP clearances?
Nasaleze International, Ltd. (2); Altamira Therapeutics, Inc. (1); Rhinix Aps (1); Hi-Tech Pharmacal, Inc. (1); Haymax Limited (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NUP
- Run a recall and safety report across every NUP manufacturer
- Watch product code NUP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Ear, Nose and Throat product codes · FDA product code lookup · 510(k) database search · 510(k) review times