# BZR: Mixer, Breathing Gases, Anesthesia Inhalation

- Device class: 2; regulation: 21 CFR 868.5330; FDA's rule: 510(k) required
- FDA decisions: 55
- 510(k) review time 2021–2025: median 206 days (middle half 160–241)
- Recalls: 1 (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)
- 2010: 1
- 2011: 2
- 2012: 2
- 2015: 1
- 2016: 1
- 2018: 1
- 2021: 1
- 2023: 4
- 2024: 1
- 2025: 1

## Most-cited predicates
- K053232: Precision Blender (2006), cited by 6
- K973646: Bird Sentry Blender/ Analyzer / Bird Sentry Low Flow Blender/Analyzer (1998), cited by 3
- K911962: Bird Sentry Air/Oxygen Microblender (1991), cited by 3
- K925982: BMD Air/Oxygen Blender (1993), cited by 3
- K090781: HELIO2 Blender (2009), cited by 2
- K960359: Aladdin Monitoring Oxygen/Air Mixer (1996), cited by 2
- K802226: Sechrist Series 3500 Air-Oxygen Mixer (1980), cited by 2
- K161718: MaxBlend 2, MaxBlend Lite (2016), cited by 2
- K883038: P/N 9320 Low Flow Air/Oxygen Microblender (1988), cited by 2
- K883833: Nitronox (R), First Response Nitronox (TM) (1989), cited by 2

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