# BTY: Calculator, Predicted Values, Pulmonary Function

- Device class: 2; regulation: 21 CFR 868.1890; FDA's rule: 510(k) required
- FDA decisions: 64
- 510(k) review time 2021–2025: median 198 days (middle half 107–268)
- 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)
- 2012: 3
- 2016: 1
- 2017: 1
- 2019: 2
- 2020: 1
- 2021: 1
- 2022: 1
- 2023: 1
- 2024: 3
- 2026: 1

## Most-cited predicates
- K942211: VMAX229 Series Pulmonary/Metabolic Systems (1994), cited by 6
- K122699: Sentrysuite Product Line (2012), cited by 3
- K082539: Masterscope, Masterscope Ecg, Masterscope CT (2008), cited by 3
- K071753: Masterscreen Pneumo & Masterscope (2007), cited by 3
- K111053: Sentrysuite Product Line (2011), cited by 2
- K000648: Spiro Pro (2000), cited by 2
- K980094: Modification to the Oxyconalpha (1998), cited by 2
- K090722: Shape-HF Cardiopulmonary Exercise Testing System (2009), cited by 2
- K933839: Master Screen Pnuemo (1994), cited by 1
- K242809: Ascent Cardiorespiratory Diagnostic Software (2024), cited by 1

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