FDA 510(k)
FDA class 2
Unknown
🇮🇱 Israel
Tyto Insights for Eardrum Bulging Detection
K Number: DEN250014
·
Decision Mar 17, 2026
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
10
Review Days
330
Basic Information
- Device Name
- Tyto Insights for Eardrum Bulging Detection
- K Number
- DEN250014
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 874.4775
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Unknown
- Applicant
- Tyto Care , Ltd.
- Date Received
- April 21, 2025
- Decision Date
- March 17, 2026
- Product Code
- SHL
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| SHL | Ear, Nose, And Throat Image Analyzer | FDA class 2 | Ear, Nose, Throat |
Other Clearances by Tyto Care , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP) | Jun 2, 2026 | Substantially Equivalent |
| K252089 | Tyto Stethoscope (G3) | Mar 12, 2026 | Substantially Equivalent |
| K243567 | Tyto Insights for Rhonchi Detection | Apr 7, 2025 | Substantially Equivalent |
| K240555 | Tyto Insights for Crackles Detection | Jul 2, 2024 | Substantially Equivalent |
| K232237 | Tyto Insights for Wheeze Detection | Dec 13, 2023 | Substantially Equivalent |
| K221614 | TytoCare Lung Sounds Analyzer | Feb 24, 2023 | Substantially Equivalent |
| K190242 | Tyto Thermometer | Mar 27, 2019 | Substantially Equivalent |
| K181612 | Tyto Stethoscope (OTC) | Dec 17, 2018 | Substantially Equivalent |
| K160401 | Tyto Stethoscope | Oct 19, 2016 | Substantially Equivalent |