# DEN250014: Tyto Insights for Eardrum Bulging Detection

- Pathway: De Novo (Direct)
- Applicant: Tyto Care, Ltd.
- Decided: Mar 17, 2026 after 330 days
- Product code: SHL (Ear, Nose, And Throat Image Analyzer)
- Device class: 2
- Regulation: 21 CFR 874.4775
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K261725: OtoCompanion (Version 1.0) (2026), 0 descendants of its own

## Indications for use
Tyto Insights for Eardrum Bulging Detection is an over-the-counter web-based AI-enabled software analytics device intended to automatically detect the bulging of the eardrum in Otoscopic video recordings acquired by the compatible electronic otoscope, as identified in the product labeling, in patients aged 6 months and older. The device is not intended for diagnosis. A healthcare provider’s advice is required to understand the meaning of the Tyto Insights for Eardrum Bulging Detection result. Healthcare providers should consider the device result in conjunction with otoscopic recordings and other relevant patient data. The device is not intended to detect other abnormal otoscopic findings.

Source page: https://510kreport.com/device/DEN250014
Methodology: https://510kreport.com/methodology