# ORC: Air Filter Portable Apparatus

- Device class: 2; regulation: 21 CFR 878.5070; FDA's rule: 510(k) required
- FDA decisions: 6
- 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)
- 2011: 1
- 2013: 1
- 2016: 1
- 2017: 2
- 2019: 1

## Most-cited predicates
- K153498: Operio (2016), cited by 2
- K123006: Air Barrier System (Abs) (2013), cited by 1
- K092801: Abs Blower, Abs Nozzle, Model 1001 (2011), cited by 1

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