Devices · Tyto Care , Ltd.

Tyto Insights for Eardrum Bulging Detection

Tyto Care , Ltd. is listed for Tyto Insights for Eardrum Bulging Detection (DEN250014). The FDA list gives March 17, 2026 as the date of the final decision. The lead panel is Ear Nose & Throat, and the database link on the FDA list is the De Novo pathway. openFDA describes product code SHL as “Ear, Nose, And Throat Image Analyzer”: An ear, nose, and throat image analyzer is a device that uses software to analyze patient-specific optical images of the ear, nose, and throat area. The results are provided to healthcare providers as an aid to detection, diagnosis, or monitoring of ear, nose, and throat conditions. openFDA records this submission’s decision description as “Unknown.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfm?id=DEN250014

Official FDA database record

Date of final decision

March 17, 2026

Company on the FDA list

Tyto Care , Ltd.

Lead panel

Ear Nose & Throat

Primary product code

SHL

openFDA device name for the code

Ear, Nose, And Throat Image Analyzer

Device class

2

Regulation number

874.4775

openFDA decision description

Unknown

openFDA decision code

DENG

Statement or summary label

Not returned