Tyto Insights for Wheeze Detection
FDA 510(k) clearance K232237 · decided 2023-12-13
Clearance details
- K-number
- K232237
- Device name
- Tyto Insights for Wheeze Detection
- Applicant
- Tyto Care , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-28
- Decision date
- 2023-12-13
- Days to decision
- 138 days
- Clearance type
- Traditional
- Product code
- PHZ
- Device class
- 2
- Regulation number
- 868.1900
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Netanya, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.