Product code FRA
- Device name
- Purifier, Air, Ultraviolet, Medical
- Medical specialty
- General Hospital
- Device class
- 2
- Regulation number
- 880.6500
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252128 | Zener® (model ZEN-001-B1) | Uvx, Inc. | 2025-09-15 |
| K241140 | ViroZap Indoor Air Purifier, In Duct Model 1008 | Applied Photonix, LLC | 2024-08-01 |
| K232642 | AirKEE T900 | Healkee Medical Pte, Ltd. | 2024-05-23 |
| K232933 | AirKEE P900 | Healkee Medical Pte, Ltd. | 2024-05-16 |
| K232645 | Airgle Room Air Purifier | Airgle Corporation | 2024-02-16 |
| K221540 | Synexis Sphere Rx | Synexis, LLC | 2023-06-14 |
| K222702 | RGS; RGS Mini | Genesis Air, Inc. | 2023-06-02 |
| K223328 | Purgo | Aeroclean Technologies, Inc. | 2022-11-30 |
| K213753 | Purgo | Aeroclean Technologies, LLC | 2022-06-01 |
| K212644 | Aura Storm | Invictus Lighting | 2022-05-26 |
| K212824 | Bluezone Model RX-450 Air Purifier | Bluezone Products, Inc. | 2022-02-17 |
| K211139 | CUBE Air Purifier | Samsung Electronics Co., Ltd. | 2021-11-26 |
| K211194 | Molekule Air Pro | Molekule, Inc. | 2021-08-20 |
| K202766 | EOS Air Cleaner | Guangzhou Ajax Medical Equipment Co., Ltd. | 2021-06-11 |
| K202339 | Molekule Air Mini, Molekule Air Mini + | Molekule, Inc. | 2021-02-23 |
| K203189 | AEROCURE-MD | Aerobiotix, Inc. | 2021-01-21 |
| K201220 | Aerus Medical Guardian,model F170A | Aerus Medical, LLC | 2020-06-17 |
| K200500 | Molekule Air Pro RX | Molekule, Inc. | 2020-04-15 |
| K161468 | Transformair Indoor Air Purifier | Transformair, LLC | 2017-02-08 |
| 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 | 2014-12-19 |
| K062716 | ECO-RX AIR PURIFIER WITH UV LIGHT, MODEL RX-400 | Eco-Rx, Inc. | 2006-10-27 |
| K052732 | ABRACAIR AIR CLEANER, MODEL QTZ300-60; ABRACAIR AIR CLEANER, MODEL TI 100-30P | Abracair, Inc. | 2006-02-24 |
| K033448 | ELECTRO-OPTICAL AIR STERILIZER WITH IONIZER | John Mfg., Ltd. | 2004-07-12 |
| K023830 | AIROCIDE TI02 | Kes Science & Technology, Inc. | 2003-02-04 |
| K980745 | SECOND WIND AIR PURIFIER | Monagan Ent., Inc. | 1999-04-02 |
| K972064 | MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV | Biological Controls, Inc. | 1997-12-01 |
| K954448 | VIOTEC V-2200 ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM | Schiff & Co. | 1996-10-28 |
| K960833 | VIOTEC S-4000-CR SECURITY SERIES ULTRAVIOLET GERMICIDAL AIR PURIFICATION SYSTEM | Uv Technologies, Inc. | 1996-07-25 |
| K951981 | RXAIR 3000 | Clean Air Research & Development | 1995-10-12 |
| K943521 | VIOTEC 1400 SERIES ULTRAVIOLET GERMICIDAL FIXTURE | Schiff & Co. | 1995-02-14 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06971608312540 | ADS | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-04-22 |
| 06971608312557 | ADS | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-04-22 |
| 06971608312564 | ADS | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-04-22 |
| 06971608312571 | ADS | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-04-22 |
| 06971608312533 | ADS | Guangzhou Ajax Medical Equipment Co., Ltd. | 2026-04-22 |
| 00860013509965 | Airgle | Airgle Corporation | 2025-06-28 |
| 00860013509972 | Airgle | Airgle Corporation | 2025-06-28 |
| 00860013509989 | Airgle | Airgle Corporation | 2025-06-28 |
| 00860013509996 | Airgle | Airgle Corporation | 2025-06-28 |
| 00860013509903 | Airgle | Airgle Corporation | 2025-05-30 |
| 00860013509910 | Airgle | Airgle Corporation | 2025-05-30 |
| 00860013509927 | Airgle | Airgle Corporation | 2025-05-30 |
| 00860013509934 | Airgle | Airgle Corporation | 2025-05-30 |
| 00860013509941 | Airgle | Airgle Corporation | 2025-05-30 |
| 00860013509958 | Airgle | Airgle Corporation | 2025-05-30 |
| 00860006970604 | Purgo | MOLEKULE, INC. | 2023-08-11 |
| 00860010611906 | RGS | Genesis Air, Inc. | 2023-07-18 |
| 00860010611913 | RGS mini | Genesis Air, Inc. | 2023-07-18 |
| 00852348007438 | Aerobiotix | AEROBIOTIX, INC. | 2022-11-15 |
| 00852348007582 | Aerobiotix | AEROBIOTIX, INC. | 2022-11-15 |
| 00852348007773 | Aerobiotix | AEROBIOTIX, INC. | 2022-02-04 |
| 00852348007568 | Aerobiotix | AEROBIOTIX, INC. | 2021-12-03 |
| 00852348007551 | Aerobiotix | AEROBIOTIX, INC. | 2021-09-03 |
| 00818701020353 | Molekule Air Pro | MOLEKULE, INC. | 2021-09-02 |
| 00860006810108 | ActivePure Medical Guardian | ACTIVEPURE MEDICAL LLC | 2021-05-12 |
| 00819355020218 | The Pyure Company | The Pyure Company Inc | 2021-04-12 |
| 00860006514808 | Medical Guardian | Aerus LLC | 2021-04-01 |
| 00818701020520 | Molekule Air Mini | MOLEKULE, INC. | 2021-02-25 |
| 00818701020537 | Molekule Air Mini + | MOLEKULE, INC. | 2021-02-25 |
| 00818701020544 | Molekule Air Mini + Retail | MOLEKULE, INC. | 2021-02-25 |