Data / Medical devices / Cleaner, Air, Medical Recirculating
Cleaner, Air, Medical Recirculating (FRF): 10 FDA-registered makers in 7 countries
10 establishments in 7 countries are registered with the FDA to make Cleaner, Air, Medical Recirculating (product code FRF, Class 2, 21 CFR 880.5045). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 53 510(k) clearances under this code, the latest on November 14, 2025, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- FRF
- Device class
- 2
- Regulation
- 880.5045
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 1 |
| Canada | 1 |
| Sweden | 1 |
| Ireland | 1 |
| Hong Kong | 1 |
| Mexico | 1 |
Makers of Cleaner, Air, Medical Recirculating
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Health-Mor, Inc | Brooklyn, OH, United States | Manufacturer | 2 | March 28, 2001 | 0 | 0 | 0 | api.fda.gov |
| Kaz USA, Inc., A Helen of Troy Company | Olive Branch, MS, United States | Manufacturer, Repackager or relabeler, Specification developer | 2 | August 25, 1994 | 0 | 0 | 0 | api.fda.gov |
| Suzhou Beiang Smart Technology Co., Ltd | Suzhou Jiangsu, China | Manufacturer | 2 | June 14, 2024 | 0 | 0 | 0 | api.fda.gov |
| Abatement Technologies Limited | FORT ERIE Ontario, Canada | Manufacturer | 1 | June 24, 1999 | 0 | 0 | 0 | api.fda.gov |
| Airsonett AB | Angelholm Skane, Sweden | Manufacturer | 1 | July 23, 2013 | 0 | 0 | 0 | api.fda.gov |
| Novaerus Us Inc. | Charlotte, NC, United States | Specification developer | 1 | December 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| Novaerus Ltd | Blackrock Dublin(County), Ireland | Manufacturer | 1 | December 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| RGF Environmental Group, Inc | Riviera Beach, FL, United States | Manufacturer | 1 | January 23, 1998 | 0 | 0 | 0 | api.fda.gov |
| Green Breeze Limited | Central, Hong Kong | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Key Tronic Juarez, S.A de C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 14, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.