# BZM: Calculator, Pulmonary Function Interpretor (Diagnostic)

- Device class: 2; regulation: 21 CFR 868.1900; FDA's rule: 510(k) required
- FDA decisions: 26
- Recalls: 0 (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)
- 1988: 2
- 1990: 1
- 1991: 1
- 1993: 1
- 1996: 1
- 1998: 2
- 2002: 1
- 2007: 1
- 2009: 1
- 2011: 1

## Most-cited predicates
- K071955: Wim-PC, Model 1010 (2007), cited by 3
- K863953: Spirometrics Model 2500 Flowmate (TM) (1987), cited by 2
- K955432: CPX, CCM, Cath with 15% CO2 (1996), cited by 2
- K980878: Pulmotrack,Model 1010 (1998), cited by 2
- K911143: PB100 Diagnostic Spirometer (1991), cited by 2
- K090863: Personal Wheezometer (2009), cited by 1
- K012387: STG Multichannel Lung Sound Analysis System (2002), cited by 1
- K923209: Medgraphics Exercise Consult (1993), cited by 1

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