Tyto Insights for Crackles Detection
FDA 510(k) K240555 · Tyto Care , Ltd.
510(k) numberK240555
Submission
- Device name
- Tyto Insights for Crackles Detection
- Applicant
- Tyto Care , Ltd.
Netanya, IL - Received
- February 28, 2024
- Decision date
- July 2, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PHZ – Abnormal Breath Sound Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1900
- Specialty
- Anesthesiology
The device is intended to measure abnormal breath sound, such as wheeze, rhonchi, and whistling.
Other 510(k)s with product code PHZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP)PHZ · Traditional | Tyto Care , Ltd. | 06/02/2026SE |
| K243567 | Tyto Insights for Rhonchi DetectionPHZ · Traditional | Tyto Care , Ltd. | 04/07/2025SE |
| K232237 | Tyto Insights for Wheeze DetectionPHZ · Traditional | Tyto Care , Ltd. | 12/13/2023SE |
| K221614 | TytoCare Lung Sounds AnalyzerPHZ · Traditional | Tyto Care , Ltd. | 02/24/2023SE |
| K202062 | wheezo WheezeRate DetectorPHZ · Traditional | Respiri Limited | 03/11/2021SE |
| K131285 | SonosentryPHZ · Traditional | Isonea, Ltd. | 08/19/2014SE |
More from Isonea, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP)PHZ · Traditional | 06/02/2026SE |
| K252089 | Tyto Stethoscope (G3)DQD · Traditional | 03/12/2026SE |
| K243567 | Tyto Insights for Rhonchi DetectionPHZ · Traditional | 04/07/2025SE |
| K232237 | Tyto Insights for Wheeze DetectionPHZ · Traditional | 12/13/2023SE |
| K221614 | TytoCare Lung Sounds AnalyzerPHZ · Traditional | 02/24/2023SE |
| K190242 | Tyto ThermometerFLL · Traditional | 03/27/2019SE |
| K181612 | Tyto Stethoscope (OTC)DQD · Traditional | 12/17/2018SE |
| K160401 | Tyto StethoscopeDQD · Traditional | 10/19/2016SE |
Questions and answers
When was Tyto Insights for Crackles Detection cleared by the FDA?
Tyto Insights for Crackles Detection (K240555) received a 510(k) decision of Substantially Equivalent on July 2, 2024, 125 days after the submission was received.
What is the product code of K240555?
The FDA product code is PHZ – Abnormal Breath Sound Device, a Class II (moderate risk) device regulated under 21 CFR 868.1900.