# BZQ: Monitor, Breathing Frequency

- Device class: 2; regulation: 21 CFR 868.2375; FDA's rule: 510(k) required
- FDA decisions: 176
- 510(k) review time 2021–2025: median 213 days (middle half 139–264)
- 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)
- 2016: 2
- 2018: 3
- 2019: 1
- 2020: 2
- 2021: 2
- 2022: 3
- 2023: 1
- 2024: 1
- 2025: 7
- 2026: 2

## Most-cited predicates
- K122223: New: Intellivue CL Respiration Pod New: Specialized Assessory: Mobile CL Resp Attachment Modified: Intellivue Patient MO (2013), cited by 6
- K923402: Crystal Trace Piezo Respiratory Effort Sensor (1992), cited by 5
- K080922: Salter Labs Oral/Nasal Thermal Airflow Sensor (2008), cited by 3
- K131379: Earlysense (2013), cited by 3
- K152911: EarlySense Insight Sytem (2016), cited by 3
- K984431: Ultima Airflow Pressure Sensor (1998), cited by 3
- K111933: Covidien Nellcor Respiration Rate Software Application, Version 1.0 (2012), cited by 3
- K090273: Kai Sensors Non-Contact Respiratory Rate Spot Check, Model 100, Kai Rspot, Model 100 (2009), cited by 3
- K941759: Snoring Sensor (1994), cited by 2
- K913749: Edentrace Airflow 3171/Sleep Lab Airflow 3170 (1992), cited by 2

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