FDA product code FRA: Purifier, Air, Ultraviolet, Medical
FRA is the FDA product code for purifier, air, ultraviolet, medical. It is a Class II device, regulated under 21 CFR 880.6500 and reviewed by the General Hospital panel. FDA has cleared 36 510(k) submissions under FRA, 11 in the last five years, from 32 different applicants. The average 510(k) review took 209 days (median 186); 132 days on average over the last three years.
Classification
| Field | Value |
|---|---|
| Device name | Purifier, Air, Ultraviolet, Medical |
| Device class | Class II |
| Regulation | 21 CFR 880.6500 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for FRA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 257 |
| 2020 | 2 | 44 |
| 2021 | 5 | 177 |
| 2022 | 4 | 165 |
| 2023 | 2 | 326 |
| 2024 | 4 | 194 |
| 2025 | 1 | 70 |
Compare with all 510(k) review times · Search every FRA clearance
Top FRA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Molekule, Inc. | 3 | 2021-08-20 |
| Healkee Medical Pte, Ltd. | 2 | 2024-05-23 |
| Schiff & Co. | 2 | 1996-10-28 |
| Uvx, Inc. | 1 | 2025-09-15 |
| Applied Photonix, LLC | 1 | 2024-08-01 |
27 more applicants have FRA clearances. See the full list in Caduvo.
Most recent FRA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252128 | Uvx, Inc. | Zener® (model ZEN-001-B1) | 2025-09-15 | 70 |
| K241140 | Applied Photonix, LLC | ViroZap Indoor Air Purifier, In Duct Model 1008 | 2024-08-01 | 99 |
| K232642 | Healkee Medical Pte, Ltd. | AirKEE T900 | 2024-05-23 | 267 |
| K232933 | Healkee Medical Pte, Ltd. | AirKEE P900 | 2024-05-16 | 239 |
| K232645 | Airgle Corporation | Airgle Room Air Purifier | 2024-02-16 | 170 |
Recalls for FRA devices
openFDA lists no recalls for product code FRA.
Frequently asked questions
What is FDA product code FRA?
FRA is the FDA product code for purifier, air, ultraviolet, medical. It is a Class II device, regulated under 21 CFR 880.6500 and reviewed by the General Hospital panel.
What device class is FRA?
Class II, regulation 21 CFR 880.6500. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRA?
Across 36 cleared submissions the average was 209 days from receipt to decision (median 186).
Which companies have the most FRA clearances?
Molekule, Inc. (3); Healkee Medical Pte, Ltd. (2); Schiff & Co. (2); Uvx, Inc. (1); Applied Photonix, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code FRA
- Run a recall and safety report across every FRA manufacturer
- Watch product code FRA for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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