# CAH: Filter, Bacterial, Breathing-Circuit

- Device class: 2; regulation: 21 CFR 868.5260; FDA's rule: 510(k) required
- FDA decisions: 202
- 510(k) review time 2021–2025: median 221 days (middle half 203–362)
- Recalls: 13 (7 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 4
- 2015: 2
- 2017: 1
- 2019: 2
- 2020: 2
- 2021: 2
- 2022: 3
- 2023: 3
- 2024: 2
- 2026: 2

## Most-cited predicates
- K934475: Koko Filter II (1993), cited by 5
- K013089: Ems Hepa Filter and Hme Combinations (2002), cited by 5
- K941381: Hygrobac,S Hygroboy and Hygrobaby (1994), cited by 4
- K033008: Air Safety Hepa and Non-Hepa Filters (2004), cited by 4
- K973314: Spirosafe Filter (1997), cited by 4
- K021265: Datex-Ohmeda Hmef 500 (2002), cited by 4
- K961914: Bacteria/Viral Filter (1996), cited by 4
- K964382: Humid-Vent Filter Compact Angled (18402)/Humid-Vent Filter Compact Straight (19402) (1997), cited by 3
- K903056: Bacttrap (1990), cited by 3
- K934272: Sensormedics Microgard Microbial Filter (1993), cited by 3

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