Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5045](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5045) → NUP — Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

# NUP · Cream, Nasal, Topical, Mechanical Allergen Particle Barrier

_General Hospital · 21 CFR 880.5045 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP

## Overview

- **Product Code:** NUP
- **Device Name:** Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
- **Regulation:** [21 CFR 880.5045](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5045)
- **Device Class:** 2
- **Review Panel:** [General Hospital](/submissions/HO)

## Identification

A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K213114](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K213114.md) | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | Jun 24, 2022 | SESE |
| [K201734](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K201734.md) | AllerBlock Junior | Nasaleze International, Ltd. | Mar 26, 2021 | SESE |
| [K170848](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K170848.md) | Alzair Allergy Blocker | Nasaleze International, Ltd. | Jun 14, 2017 | SESE |
| [K134003](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K134003.md) | RHINIX NASAL FILTER | Rhinix Aps | Sep 4, 2014 | SESE |
| [K132520](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K132520.md) | NASAL EASE ALLERGY BLOCKER | Hi-Tech Pharmacal, Inc. | Dec 31, 2013 | SESE |
| [K120894](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K120894.md) | HAYMAX | Haymax Limited | May 17, 2012 | SESE |
| [K053625](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K053625.md) | NASALGUARD | Trutek Corp | Feb 22, 2006 | SESE |
| [K042610](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K042610.md) | DR. THEISS ALERGOL POLLEN BLOCKER CREAM | Dr. Theiss Naturwaren GmbH | May 16, 2005 | SESE |

## Top Applicants

- Nasaleze International, Ltd. — 2 clearances
- Altamira Therapeutics, Inc. — 1 clearance
- Dr. Theiss Naturwaren GmbH — 1 clearance
- Haymax Limited — 1 clearance
- Hi-Tech Pharmacal, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP)

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