FRA · Purifier, Air, Ultraviolet, Medical
General Hospital · 21 CFR 880.6500 · Class 2
Overview
| Product Code | FRA |
|---|---|
| Device Name | Purifier, Air, Ultraviolet, Medical |
| Regulation | 21 CFR 880.6500 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 | Zener® (model ZEN-001-B1) | Uvx, Inc. | Sep 15, 2025 | SESE |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC | Aug 1, 2024 | SESE |
| K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | May 23, 2024 | SESE |
| K232933 | AirKEE P900 | Healkee Medical Pte, Ltd. | May 16, 2024 | SESE |
| K232645 | Airgle Room Air Purifier | Airgle Corporation | Feb 16, 2024 | SESE |
| K221540 | Synexis Sphere Rx | Synexis, LLC | Jun 14, 2023 | SESE |
| K222702 | RGS; RGS Mini | Genesis Air, Inc. | Jun 2, 2023 | SESE |
| K223328 | Purgo | Aeroclean Technologies, Inc. | Nov 30, 2022 | SESE |
| K213753 | Purgo | Aeroclean Technologies, LLC | Jun 1, 2022 | SESE |
| K212644 | Aura Storm | Invictus Lighting | May 26, 2022 | SESE |
| K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | Feb 17, 2022 | SESE |
| K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | Nov 26, 2021 | SESE |
| K211194 | Molekule Air Pro | Molekule, Inc. | Aug 20, 2021 | SESE |
| K202766 | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. | Jun 11, 2021 | SESE |
| K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | Feb 23, 2021 | SESE |
| K203189 | AEROCURE-MD | Aerobiotix, Inc. | Jan 21, 2021 | SESE |
| K201220 | Aerus Medical Guardian,model F170A | Aerus Medical, LLC | Jun 17, 2020 | SESE |
| K200500 | Molekule Air Pro RX | Molekule, Inc. | Apr 15, 2020 | SESE |
| K161468 | Transformair Indoor Air Purifier | Transformair, LLC | Feb 8, 2017 | SESE |
| K133800 | 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
