FRA — Purifier, Air, Ultraviolet, Medical Class II
FDA Device Classification
Classification Details
- Product Code
- FRA
- Device Class
- Class II
- Regulation Number
- 880.6500
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K252128 | uvx | Zener® (model ZEN-001-B1) | September 15, 2025 |
| K241140 | applied photonix | ViroZap Indoor Air Purifier, In Duct Model 1008 | August 1, 2024 |
| K232642 | healkee medical pte | AirKEE T900 | May 23, 2024 |
| K232933 | healkee medical pte | AirKEE P900 | May 16, 2024 |
| K232645 | airgle corporation | Airgle Room Air Purifier | February 16, 2024 |
| K221540 | synexis | Synexis Sphere Rx | June 14, 2023 |
| K222702 | genesis air | RGS; RGS Mini | June 2, 2023 |
| K223328 | aeroclean technologies | Purgo | November 30, 2022 |
| K213753 | aeroclean technologies | Purgo | June 1, 2022 |
| K212644 | invictus lighting | Aura Storm | May 26, 2022 |
| K212824 | bluezone products | Bluezone Model RX-450 Air Purifier | February 17, 2022 |
| K211139 | samsung electronics co | CUBE Air Purifier | November 26, 2021 |
| K211194 | molekule | Molekule Air Pro | August 20, 2021 |
| K202766 | guangzhou ajax medical equipment co | EOS Air Cleaner | June 11, 2021 |
| K202339 | molekule | Molekule Air Mini, Molekule Air Mini + | February 23, 2021 |
| K203189 | aerobiotix | AEROCURE-MD | January 21, 2021 |
| K201220 | aerus medical | Aerus Medical Guardian,model F170A | June 17, 2020 |
| K200500 | molekule | Molekule Air Pro RX | April 15, 2020 |
| K161468 | transformair | Transformair Indoor Air Purifier | February 8, 2017 |
| K133800 | hgi industires | ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION | December 19, 2014 |