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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 / June 2026 / K252844

510(k) cleared

Tyto Insights for Wheeze Detection (with PCCP)

Tyto Care , Ltd. · Jun 2, 2026 · K252844

FDA cleared the Tyto Insights for Wheeze Detection (with PCCP) from Tyto Care , Ltd. on Jun 2, 2026 under K252844, a traditional 510(k). The device falls under product code PHZ, Abnormal Breath Sound Device, regulated at 21 CFR 868.1900 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 8, 2025. The decision came 267 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: DEN250014 (Tyto Insights for Eardrum Bulging Detection), K252089 (Tyto Stethoscope (G3)).

Questions & Answers

What did FDA clear under K252844?

K252844 is the FDA 510(k) for Tyto Insights for Wheeze Detection (with PCCP), submitted by Tyto Care , Ltd.. FDA's decision date was Jun 2, 2026, under product code PHZ (Abnormal Breath Sound Device).

Who makes the Tyto Insights for Wheeze Detection (with PCCP)?

Tyto Care , Ltd., based in Netanya, is the applicant of record for K252844.

How long did the K252844 review take?

FDA received the submission on Sep 8, 2025 and issued its decision on Jun 2, 2026, 267 days later.

← All decisions in June 2026

Sources