# CBN: Apparatus, Gas-Scavenging

- Device class: 2; regulation: 21 CFR 868.5430; FDA's rule: 510(k) required
- FDA decisions: 43
- 510(k) review time 2021–2025: median 110 days (middle half 110–110)
- Recalls: 3 (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)
- 2006: 1
- 2007: 1
- 2008: 1
- 2010: 1
- 2011: 1
- 2013: 1
- 2014: 2
- 2017: 1
- 2020: 1
- 2023: 1

## Most-cited predicates
- K080039: Passive Waste Gas Scavenger, Model 14600 (2008), cited by 2
- K842003: Ohio Waste Gas Scavenging Interface (1984), cited by 2
- K110930: Active Waste Gas Scavenger (2011), cited by 1
- K965239: Pip Low Profile Scavenging System (260 and 261)/Universal Low Profile Scavenging System (260-U and 261-U) (1997), cited by 1
- K802067: Clean-Air Pollution Reduction System (1980), cited by 1
- K790333: Nad Scavenging Relief Valve (1979), cited by 1
- K033503: RFS Vacuum Gauge Scavenging Circuit (2004), cited by 1
- K063519: Dynamic Gas Scavenging System (DGSS) (2006), cited by 1
- K123176: Iso-Gard Clearair Mask (2013), cited by 1
- K033028: Anefin, Model 100 (2005), cited by 1

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