FRA
- Product code
- FRA
- Device name
- Purifier, Air, Ultraviolet, Medical
- Device class
- Class 2
- 21 CFR
- 21 CFR 880.6500
- Medical specialty
- General Hospital
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 36 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252128 | 2025-09-15 | Uvx, Inc. | Zener® (model ZEN-001-B1) | |
| K241140 | 2024-08-01 | Applied Photonix, LLC | ViroZap Indoor Air Purifier, In Duct Model 1008 | FDA |
| K232642 | 2024-05-23 | Healkee Medical Pte, Ltd. | AirKEE T900 | |
| K232933 | 2024-05-16 | Healkee Medical Pte, Ltd. | AirKEE P900 | |
| K232645 | 2024-02-16 | Airgle Corporation | Airgle Room Air Purifier |
Official FDA classification page: FRA
Classification and pathway per current FDA publications. Data from openFDA (CC0).