DEN250014 - Tyto Insights for Eardrum Bulging Detection (FDA 510(k) Clearance)

DEN250014 is an FDA 510(k) submission (not cleared) for the Tyto Insights for Eardrum Bulging Detection.

Submitted by Tyto Care , Ltd. (Netanya, IL). The FDA issued a Not Cleared (DENG) decision on March 17, 2026 after a review of 330 days.

This device falls under the Ear, Nose, Throat FDA review panel. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 330 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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