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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / DEN250014

510(k) cleared

Tyto Insights for Eardrum Bulging Detection

Tyto Care , Ltd. · Mar 17, 2026 · DEN250014

FDA cleared the Tyto Insights for Eardrum Bulging Detection from Tyto Care , Ltd. on Mar 17, 2026 under DEN250014, a direct 510(k). The device falls under product code SHL, Ear, Nose, And Throat Image Analyzer, regulated at 21 CFR 874.4775 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Apr 21, 2025. The decision came 330 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Tyto Care , Ltd. has 2 other decisions in the tracker over the last 12 months: K252844 (Tyto Insights for Wheeze Detection (with PCCP)), K252089 (Tyto Stethoscope (G3)).

Questions & Answers

What did FDA clear under DEN250014?

DEN250014 is the FDA 510(k) for Tyto Insights for Eardrum Bulging Detection, submitted by Tyto Care , Ltd.. FDA's decision date was Mar 17, 2026, under product code SHL (Ear, Nose, And Throat Image Analyzer).

Who makes the Tyto Insights for Eardrum Bulging Detection?

Tyto Care , Ltd., based in Netanya, is the applicant of record for DEN250014.

How long did the DEN250014 review take?

FDA received the submission on Apr 21, 2025 and issued its decision on Mar 17, 2026, 330 days later.

← All decisions in March 2026

Sources