# FRA: Purifier, Air, Ultraviolet, Medical

- Device class: 2; regulation: 21 CFR 880.6500; FDA's rule: 510(k) required
- FDA decisions: 36
- 510(k) review time 2021–2025: median 187 days (middle half 116–264)
- Recalls: 0 (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)
- 2004: 1
- 2006: 2
- 2014: 1
- 2017: 1
- 2020: 2
- 2021: 5
- 2022: 4
- 2023: 2
- 2024: 4
- 2025: 1

## Most-cited predicates
- K200500: Molekule Air Pro RX (2020), cited by 4
- K202339: Molekule Air Mini, Molekule Air Mini + (2021), cited by 3
- K212644: Aura Storm (2022), cited by 3
- K161468: Transformair Indoor Air Purifier (2017), cited by 3
- K211194: Molekule Air Pro (2021), cited by 2
- K972064: Microcon 800MUV, Microcon 400MUV, Microcon Exc-Buv (1997), cited by 2
- K023830: Airocide TI02 (2003), cited by 2
- K062716: Eco-RX Air Purifier with UV Light, Model RX-400 (2006), cited by 2
- K133800: Odorox (R) Idu/RX (TM) in-Duct Models, Odorox (R) Idu/RX (TM) Mobile Disinfection Units, Odorox (R) Slimline/RX (TM) Slimli (2014), cited by 1
- K213753: Purgo (2022), cited by 1

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