FDA product code FRF: Cleaner, Air, Medical Recirculating
FRF is the FDA product code for cleaner, air, medical recirculating. It is a Class II device, regulated under 21 CFR 880.5045 and reviewed by the General Hospital panel. FDA has cleared 53 510(k) submissions under FRF, 8 in the last five years, from 48 different applicants. The average 510(k) review took 193 days (median 149); 128 days on average over the last three years. FDA has posted 1 recall for FRF devices.
Classification
| Field | Value |
|---|---|
| Device name | Cleaner, Air, Medical Recirculating |
| Device class | Class II |
| Regulation | 21 CFR 880.5045 |
| 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 FRF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2020 | 1 | 322 |
| 2022 | 3 | 290 |
| 2023 | 2 | 267 |
| 2024 | 2 | 108 |
| 2025 | 1 | 149 |
Compare with all 510(k) review times · Search every FRF clearance
Top FRF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hmi Industries, Inc. | 2 | 2001-03-28 |
| The Rival Co. | 2 | 1995-06-16 |
| Bionaire Corp. | 2 | 1994-12-14 |
| Norelco Consumer Products Co. | 2 | 1994-11-28 |
| Medicor USA , Ltd. | 2 | 1985-07-01 |
43 more applicants have FRF clearances. See the full list in Caduvo.
Most recent FRF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251872 | Biomoneta Research Private Limited | Biomoneta Avata Rx | 2025-11-14 | 149 |
| K242102 | Cerrozone, LLC | CerroZone Mini | 2024-11-19 | 124 |
| K240696 | Suzhou Beiang Smart Technology Co., Ltd. | Airdog X8 Air Purifier (KJ800F-X8) | 2024-06-14 | 92 |
| K223835 | Medify Air, LLC | MA-40, MA-112 | 2023-09-18 | 270 |
| K222416 | Ria Tech Co., Ltd. | RIA Safeguard | 2023-05-01 | 264 |
Recalls for FRF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-01-09.
Frequently asked questions
What is FDA product code FRF?
FRF is the FDA product code for cleaner, air, medical recirculating. It is a Class II device, regulated under 21 CFR 880.5045 and reviewed by the General Hospital panel.
What device class is FRF?
Class II, regulation 21 CFR 880.5045. Typical premarket route: 510(k).
How long does a 510(k) take for product code FRF?
Across 53 cleared submissions the average was 193 days from receipt to decision (median 149).
Which companies have the most FRF clearances?
Hmi Industries, Inc. (2); The Rival Co. (2); Bionaire Corp. (2); Norelco Consumer Products Co. (2); Medicor USA , Ltd. (2).
Have FRF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-01-09.
Next steps
- Run an FDA pathway report with predicate devices for product code FRF
- Run a recall and safety report across every FRF manufacturer
- Watch product code FRF 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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