# PHZ: Abnormal Breath Sound Device

- Device class: 2; regulation: 21 CFR 868.1900; FDA's rule: 510(k) required
- FDA decisions: 8
- 510(k) review time 2021–2025: median 140 days (middle half 138–227)
- 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
- 2021: 1
- 2023: 2
- 2024: 1
- 2025: 1
- 2026: 2

## Most-cited predicates
- K232237: Tyto Insights for Wheeze Detection (2023), cited by 3
- K202062: wheezo WheezeRate Detector (2021), cited by 1
- K221614: TytoCare Lung Sounds Analyzer (2023), cited by 1
- K131285: Sonosentry (2014), cited by 1
- K240555: Tyto Insights for Crackles Detection (2024), cited by 1

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