PHZ
7 FDA 510(k) clearances · Product code
227 daysmedian time to decision
470 days90th percentile
7clearances measured
FDA profile
- Official device name
- Abnormal Breath Sound Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1900
- Medical specialty
- Anesthesiology
- Flags
- Third-party review eligible
- FDA definition
- The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Tyto Insights for Wheeze Detection (with PCCP) (K252844) | Tyto Care , Ltd. | 2026-06-02 |
| Tyto Insights for Rhonchi Detection (K243567) | Tyto Care , Ltd. | 2025-04-07 |
| Tyto Insights for Crackles Detection (K240555) | Tyto Care , Ltd. | 2024-07-02 |
| Tyto Insights for Wheeze Detection (K232237) | Tyto Care , Ltd. | 2023-12-13 |
| TytoCare Lung Sounds Analyzer (K221614) | Tyto Care , Ltd. | 2023-02-24 |
| wheezo WheezeRate Detector (K202062) | Respiri Limited | 2021-03-11 |
| SONOSENTRY (K131285) | Isonea, Ltd. | 2014-08-19 |
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Every clearance here is in the API, with alerts when new ones post.