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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 / K252089

510(k) cleared

Tyto Stethoscope (G3)

Tyto Care , Ltd. · Mar 12, 2026 · K252089

FDA cleared the Tyto Stethoscope (G3) from Tyto Care , Ltd. on Mar 12, 2026 under K252089, a traditional 510(k). The device falls under product code DQD, Stethoscope, Electronic, regulated at 21 CFR 870.1875 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jul 2, 2025. The decision came 253 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)), DEN250014 (Tyto Insights for Eardrum Bulging Detection).

Questions & Answers

What did FDA clear under K252089?

K252089 is the FDA 510(k) for Tyto Stethoscope (G3), submitted by Tyto Care , Ltd.. FDA's decision date was Mar 12, 2026, under product code DQD (Stethoscope, Electronic).

Who makes the Tyto Stethoscope (G3)?

Tyto Care , Ltd., based in Netanya, is the applicant of record for K252089.

How long did the K252089 review take?

FDA received the submission on Jul 2, 2025 and issued its decision on Mar 12, 2026, 253 days later.

← All decisions in March 2026

Sources