# FRF: Cleaner, Air, Medical Recirculating

- Device class: 2; regulation: 21 CFR 880.5045; FDA's rule: 510(k) required
- FDA decisions: 53
- 510(k) review time 2021–2025: median 156 days (middle half 143–266)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2002: 1
- 2003: 1
- 2007: 1
- 2008: 2
- 2013: 2
- 2020: 1
- 2022: 3
- 2023: 2
- 2024: 2
- 2025: 1

## Most-cited predicates
- K981841: Breathe Easy, Models AD and CD (1998), cited by 3
- K200321: Novaerus NV1050 (2020), cited by 3
- K974682: Microcon 800M, Microcon 400M, Microcon Exc, Microcon EX, Microcon Wallmap (1998), cited by 2
- K872359: Enviracaire Model EV-1 (1987), cited by 1
- K984116: Hepa-Care Air Cleaner American Air Filter Air Filtration System Models HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400C (1999), cited by 1
- K070722: Plasmair, Model T2006 (2007), cited by 1
- K012549: Advanced Air Purification System; Hepa Air Cleaning System (2002), cited by 1
- K220298: CerroZone Mobile (2022), cited by 1
- K211507: Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) (2022), cited by 1
- K112728: Hepairx Ventilating Air Purifier (2013), cited by 1

Source page: https://510kreport.com/product-code/FRF
Data by year (CSV): https://510kreport.com/product-code/FRF.csv