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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 / August 2026 / K261499

510(k) cleared

TrachFlush

Aw Technologies Aps · Aug 13, 2026 · K261499

FDA cleared the TrachFlush from Aw Technologies Aps on Aug 13, 2026 under K261499, a traditional 510(k). The device falls under product code BSK, Cuff, Tracheal Tube, Inflatable, regulated at 21 CFR 868.5750 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 6, 2026. The decision came 99 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 Aw Technologies Aps in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261499?

K261499 is the FDA 510(k) for TrachFlush, submitted by Aw Technologies Aps. FDA's decision date was Aug 13, 2026, under product code BSK (Cuff, Tracheal Tube, Inflatable).

Who makes the TrachFlush?

Aw Technologies Aps, based in Norresundby, is the applicant of record for K261499.

How long did the K261499 review take?

FDA received the submission on May 6, 2026 and issued its decision on Aug 13, 2026, 99 days later.

← All decisions in August 2026