FRA — Purifier, Air, Ultraviolet, Medical Class II
FDA product code FRA covers "Purifier, Air, Ultraviolet, Medical", a Class II medical device regulated under 21 CFR 880.6500. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |