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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 / April 2026 / K252436

510(k) cleared

Tula Tympanostomy Tube Delivery Device

Tusker Medical, Inc. · Apr 23, 2026 · K252436

FDA cleared the Tula Tympanostomy Tube Delivery Device from Tusker Medical, Inc. on Apr 23, 2026 under K252436, a traditional 510(k). The device falls under product code ETD, Tube, Tympanostomy, regulated at 21 CFR 874.3880 as a Class 2 device. The review panel was Ear, Nose, Throat.

FDA logged the submission as received on Aug 1, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Tusker Medical, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252436?

K252436 is the FDA 510(k) for Tula Tympanostomy Tube Delivery Device, submitted by Tusker Medical, Inc.. FDA's decision date was Apr 23, 2026, under product code ETD (Tube, Tympanostomy).

Who makes the Tula Tympanostomy Tube Delivery Device?

Tusker Medical, Inc., based in Austin, TX, is the applicant of record for K252436.

How long did the K252436 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Apr 23, 2026, 265 days later.

← All decisions in April 2026