# BZG: Spirometer, Diagnostic

- Device class: 2; regulation: 21 CFR 868.1840; FDA's rule: 510(k) required
- FDA decisions: 228
- 510(k) review time 2021–2025: median 282 days (middle half 222–369)
- 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)
- 2016: 4
- 2017: 2
- 2018: 1
- 2019: 3
- 2020: 5
- 2021: 1
- 2022: 2
- 2023: 5
- 2024: 2
- 2026: 1

## Most-cited predicates
- K072979: Spirobank G (2007), cited by 7
- K971336: Caird Technology Spirometer (1998), cited by 5
- K052158: Welch Allyn Cardioperfect Workstation Version 1.5.0 Software (2005), cited by 5
- K993921: NDD Medical Technologies Easyone Spirometer: Frontline Model 2000 and Diagnostic Model 2001 (2000), cited by 4
- K100687: Vitalograph Hand Held Spirometer, Model 2120 (2010), cited by 4
- K031102: Microlab Spirometer (2003), cited by 4
- K944762: Puritan-Bennett Renaissance Spirometry Systemwith the Optionalrenaissance DB Data Managementsoftware (1994), cited by 4
- K914085: HMS-5000 (1991), cited by 3
- K913396: Cannula Style Thermocouples (1992), cited by 3
- K992743: Collins CPL (1999), cited by 3

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