# BZK: Spirometer, Monitoring (W/Wo Alarm)

- Device class: 2; regulation: 21 CFR 868.1850; FDA's rule: 510(k) required
- FDA decisions: 62
- Recalls: 2 (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)
- 2006: 1
- 2008: 1
- 2009: 3
- 2011: 1
- 2012: 1
- 2013: 1
- 2017: 1
- 2018: 2
- 2019: 2
- 2026: 1

## Most-cited predicates
- K932098: Capnomac  Ultima Anesthesia Monitor (1993), cited by 2
- K901885: Partner Volume Monitor (1990), cited by 2
- K120087: Exspiron (2012), cited by 2
- K062754: Gas Module SE, Model 0998-00-0481-02 (2006), cited by 2
- K173181: ExSpiron 1Xi (2018), cited by 2
- K103578: Philips NM3 Respiratory Monitor with Ventassist (2011), cited by 2
- K091459: Philips NM3 Monitor, Model 7900 (2009), cited by 1
- K864886: Respigraph-Respisomnograph-Respicentral (1987), cited by 1
- K130170: Exspiron 1XI (2013), cited by 1
- K080652: Mercury VCO2 Module with Capnostat 5 (2008), cited by 1

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