Abnormal Breath Sound Device
The Abnormal Breath Sound Device is a diagnostic device intended to measure abnormal breath sounds such as wheezes, rhonchi, and whistling, providing objective acoustic data to support respiratory assessment. It is an FDA Class 2 device regulated under 21 CFR 868.1900, requiring 510(k) premarket notification, within the Anesthesiology (AN) medical specialty. The product code is PHZ, and it is eligible for third-party review. This device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PHZ
- Device Class
- FDA class 2
- Regulation Number
- 868.1900
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 1
Device Characteristics
Definition
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Jun 02, 2026 | Substantially Equivalent | Tyto Care , Ltd. |
| K243567 | Tyto Insights for Rhonchi Detection | Apr 07, 2025 | Substantially Equivalent | Tyto Care , Ltd. |
| K240555 | Tyto Insights for Crackles Detection | Jul 02, 2024 | Substantially Equivalent | Tyto Care , Ltd. |
| K232237 | Tyto Insights for Wheeze Detection | Dec 13, 2023 | Substantially Equivalent | Tyto Care , Ltd. |
| K221614 | TytoCare Lung Sounds Analyzer | Feb 24, 2023 | Substantially Equivalent | Tyto Care , Ltd. |
| K202062 | wheezo WheezeRate Detector | Mar 11, 2021 | Substantially Equivalent | Respiri Limited |
| K131285 | SONOSENTRY | Aug 19, 2014 | Substantially Equivalent | Isonea, Ltd. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.