# BZH: Meter, Peak Flow, Spirometry

- Device class: 2; regulation: 21 CFR 868.1860; FDA's rule: 510(k) required
- FDA decisions: 81
- 510(k) review time 2021–2025: median 371 days (middle half 232–458)
- 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)
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 3
- 2019: 1
- 2020: 2
- 2021: 1
- 2023: 1
- 2024: 3
- 2026: 2

## Most-cited predicates
- K926307: Peak Flow Meter (1993), cited by 4
- K040723: Microlife Electronic Peak Flow Monitor, with Pef and FEV1, Models PF-100 and PF-100-1 (with Software) (2004), cited by 4
- K030586: Micropeak (2003), cited by 3
- K781922: Pulmonary Monitor (1979), cited by 3
- K982995: Accutrax, Model EPF840 (1998), cited by 3
- K152276: Wing Smart FEVI and Peak Flow Meter (2016), cited by 3
- K955234: Trupeak Peak Flow Meter (1996), cited by 2
- K170281: MSA100BT Peak Flow Meter (2017), cited by 2
- K010009: Koko Peak KP; Koko Peak KP+ (2001), cited by 2
- K050853: PMP4 Spiropro (2005), cited by 2

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