# CAD: Vaporizer, Anesthesia, Non-Heated

- Device class: 2; regulation: 21 CFR 868.5880; FDA's rule: 510(k) required
- FDA decisions: 57
- 510(k) review time 2021–2025: median 267 days (middle half 267–267)
- Recalls: 10 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2001: 1
- 2002: 1
- 2003: 1
- 2004: 2
- 2005: 1
- 2006: 2
- 2011: 1
- 2015: 1
- 2018: 1
- 2024: 1

## Most-cited predicates
- K942091: Ohmeda Tec 5 Vaporizer for Use with Sevoflurane (1995), cited by 5
- K000275: Datex-Ohmeda Tec 6 Plus Anesthesia Vaporizer, Datex-Ohmeda Tec 6 Plus Nad Variant Anesthesia (2000), cited by 3
- K892057: Ohmeda Tec 5 Continuous Flow Vaporizer (1989), cited by 3
- K042276: D-Vapor (2004), cited by 2
- K841157: Halothane Vaporizer 950, Enflurane (1984), cited by 2
- K971923: Drager-Vapor 2000 (1997), cited by 2
- K012924: Datex-Ohmeda Tec 7 Anesthesia Vaporizer (2002), cited by 2
- K942055: Drager-Vapor 19.1 (1995), cited by 2
- K002343: Sigma Delta (2001), cited by 2
- K771899: VAPOR 19 (1977), cited by 1

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