# BZC: Calculator, Pulmonary Function Data

- Device class: 2; regulation: 21 CFR 868.1880; FDA's rule: 510(k) required
- FDA decisions: 90
- 510(k) review time 2021–2025: median 229 days (middle half 229–229)
- 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)
- 2005: 1
- 2007: 1
- 2011: 1
- 2014: 2
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2019: 2
- 2024: 1

## Most-cited predicates
- K150810: Vyntus / SentrySuite Product Line (2015), cited by 4
- K982499: Cosmo Plus with Nico, Model 8200 (1998), cited by 3
- K963380: CO 2 Smo Plus (1997), cited by 3
- K001174: Cosmed Quark (2001), cited by 2
- K133925: Vyntus/ Sentrysuite Product Line (2014), cited by 2
- K052328: Zan Lung-Function Lab (2005), cited by 2
- K900696: Biore CP-100 Cardiopulmonary Monitor (1990), cited by 2
- K831779: Collins Eagle II (1983), cited by 1
- K133051: Pulmone Minibox PFT TM (2014), cited by 1
- K011344: Infant Plethysmograph, Model 004400; Pediatric Plethysmograph, Model 004400 (2002), cited by 1

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