Haymax
510(k) K120894
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK120894 | Date17 May 2012 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NUP
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5045
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Haymax Nasal Allergen Particle Barrier Cream is a Nasal, Topical, Mechanical Allergen Particle Barrier Cream, classified under FDA product code NUP. This device is designed to create a physical barrier within the nasal passages to reduce the impact of airborne allergens, helping to alleviate symptoms associated with allergic rhinitis.
This cream is supplied as a single-use topical application for nasal use and is intended for over-the-counter administration in general hospital settings. It is classified as a Class II medical device under FDA regulations (880.5045) and has received FDA 510(k) clearance as substantially equivalent to predicate devices. Sterility and packaging details are not specified, but it is intended for direct application by the user.
Questions
AI-generated answers, 19 Sep 2026
What is the primary purpose of the Haymax Nasal Allergen Particle Barrier Cream, and how does it work?
The Haymax Nasal Allergen Particle Barrier Cream is designed to create a physical barrier within the nasal passages to reduce exposure to airborne allergens. By forming a protective layer, it helps minimize the impact of allergens that can trigger symptoms of allergic rhinitis, such as sneezing, itching, or congestion.
Is this cream intended for single-use or repeated applications, and how is it supplied?
The Haymax Nasal Allergen Particle Barrier Cream is supplied as a single-use topical application for nasal use. It is intended for direct application by the user, meaning each tube or package is meant for one-time use.
What types of medical settings is this device approved for use in?
The device is classified under the FDA product code NUP and is intended for over-the-counter administration in general hospital settings, though it is also suitable for broader use in clinical environments where nasal allergen management is required.
How is the regulatory status of this device determined, and what does that mean for its use?
The Haymax Nasal Allergen Particle Barrier Cream has received FDA 510(k) clearance, which means it is classified as substantially equivalent to predicate devices and is approved as a Class II medical device under FDA regulations (880.5045). This clearance indicates it meets the necessary safety and effectiveness standards for over-the-counter use in managing nasal allergen symptoms.
Are there different sizes or models of this cream available, and how would I identify them?
The provided data does not specify distinct sizes or models for the Haymax Nasal Allergen Particle Barrier Cream, but it is listed under multiple registration numbers (e.g., 3011788145, 3013037032) which may correspond to variations in packaging or formulations. For precise details on available models, it is best to consult the manufacturer’s documentation or contact Haymax Limited directly.