Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6500](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6500) → FRA — Purifier, Air, Ultraviolet, Medical # FRA · Purifier, Air, Ultraviolet, Medical _General Hospital · 21 CFR 880.6500 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA ## Overview - **Product Code:** FRA - **Device Name:** Purifier, Air, Ultraviolet, Medical - **Regulation:** [21 CFR 880.6500](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6500) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## Identification A medical ultraviolet air purifier is a device intended for medical purposes that is used to destroy bacteria in the air by exposure to ultraviolet radiation. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 36) Showing 20 most recent of 36 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K252128](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K252128.md) | Zener® (model ZEN-001-B1) | Uvx, Inc. | Sep 15, 2025 | SESE | | [K241140](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K241140.md) | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC | Aug 1, 2024 | SESE | | [K232642](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K232642.md) | AirKEE T900 | Healkee Medical Pte, Ltd. | May 23, 2024 | SESE | | [K232933](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K232933.md) | AirKEE P900 | Healkee Medical Pte, Ltd. | May 16, 2024 | SESE | | [K232645](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K232645.md) | Airgle Room Air Purifier | Airgle Corporation | Feb 16, 2024 | SESE | | [K221540](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K221540.md) | Synexis Sphere Rx | Synexis, LLC | Jun 14, 2023 | SESE | | [K222702](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K222702.md) | RGS; RGS Mini | Genesis Air, Inc. | Jun 2, 2023 | SESE | | [K223328](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K223328.md) | Purgo | Aeroclean Technologies, Inc. | Nov 30, 2022 | SESE | | [K213753](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K213753.md) | Purgo | Aeroclean Technologies, LLC | Jun 1, 2022 | SESE | | [K212644](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K212644.md) | Aura Storm | Invictus Lighting | May 26, 2022 | SESE | | [K212824](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K212824.md) | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | Feb 17, 2022 | SESE | | [K211139](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K211139.md) | CUBE Air Purifier | Samsung Electronics Co., Ltd. | Nov 26, 2021 | SESE | | [K211194](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K211194.md) | Molekule Air Pro | Molekule, Inc. | Aug 20, 2021 | SESE | | [K202766](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K202766.md) | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. | Jun 11, 2021 | SESE | | [K202339](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K202339.md) | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | Feb 23, 2021 | SESE | | [K203189](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K203189.md) | AEROCURE-MD | Aerobiotix, Inc. | Jan 21, 2021 | SESE | | [K201220](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K201220.md) | Aerus Medical Guardian,model F170A | Aerus Medical, LLC | Jun 17, 2020 | SESE | | [K200500](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K200500.md) | Molekule Air Pro RX | Molekule, Inc. | Apr 15, 2020 | SESE | | [K161468](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K161468.md) | Transformair Indoor Air Purifier | Transformair, LLC | Feb 8, 2017 | SESE | | [K133800](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA/K133800.md) | ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI | Hgi Industires | Dec 19, 2014 | SESE | ## Top Applicants - Molekule, Inc. — 3 clearances - Healkee Medical Pte, Ltd. — 2 clearances - Schiff & Co. — 2 clearances - Abracair, Inc. — 1 clearance - Aerobiotix, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRA) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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