Name: Predicase
Price: 199 USD

K-number	DEN250014
Device name	Tyto Insights for Eardrum Bulging Detection
Applicant	Tyto Care , Ltd.
Product code	SHL
Device class	Class II
Decision date	Mar 17, 2026
Decision	Not Substantially Equivalent
Regulation	874.4775

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Tyto Insights for Eardrum Bulging Detection

Everything you need for a 510(k) submission. Nothing you don't.