# BSZ: Gas-Machine, Anesthesia

- Device class: 2; regulation: 21 CFR 868.5160; FDA's rule: 510(k) required
- FDA decisions: 189
- 510(k) review time 2021–2025: median 183 days (middle half 101–310)
- Recalls: 117 (38 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: 4
- 2016: 1
- 2017: 3
- 2018: 2
- 2020: 1
- 2021: 1
- 2023: 2
- 2025: 1
- 2026: 2

## Most-cited predicates
- K973985: AS/3 Anaesthesia Delivery Unit (as/3 Adu) (1998), cited by 6
- K090233: GE Datex-Ohmeda Aisys (2009), cited by 5
- K000706: Datex-Ohmeda Aestiva/5 with 7100 Ventilator (2000), cited by 4
- K042607: Primus US (2004), cited by 4
- K071097: Navigator Applications Suite (2007), cited by 4
- K050055: GE Datex-Ohmeda Aestiva/5 Mri Anesthesia System (2005), cited by 4
- K030939: Philips Compurecord Peri-Operative Information System Software (2003), cited by 4
- K040743: Modification to Datex-Ohmeda S/5 Avance Anesthesia System (2004), cited by 3
- K123211: A5 Anesthesia Delivery System (2013), cited by 3
- K081844: GE Datex-Ohmeda Avance (2008), cited by 3

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