WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / February 2026 / K260308

510(k) cleared

TrueFit Bolus

Adaptiiv Medical Technologies, Inc. · Feb 19, 2026 · K260308

FDA cleared the TrueFit Bolus from Adaptiiv Medical Technologies, Inc. on Feb 19, 2026 under K260308, a special 510(k). The device falls under product code MUJ, System, Planning, Radiation Therapy Treatment, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jan 30, 2026. The decision came 20 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260308?

K260308 is the FDA 510(k) for TrueFit Bolus, submitted by Adaptiiv Medical Technologies, Inc.. FDA's decision date was Feb 19, 2026, under product code MUJ (System, Planning, Radiation Therapy Treatment).

Who makes the TrueFit Bolus?

Adaptiiv Medical Technologies, Inc., based in Halifax, is the applicant of record for K260308.

How long did the K260308 review take?

FDA received the submission on Jan 30, 2026 and issued its decision on Feb 19, 2026, 20 days later.

← All decisions in February 2026