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 / November 2025 / K252133

510(k) cleared

Adaptix Ortho350

Adaptix Limited · Nov 6, 2025 · K252133

FDA cleared the Adaptix Ortho350 from Adaptix Limited on Nov 6, 2025 under K252133, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code IZF, System, X-Ray, Tomographic, regulated at 21 CFR 892.1740 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Jul 7, 2025. The decision came 122 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 Adaptix Limited in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252133?

K252133 is the FDA 510(k) for Adaptix Ortho350, submitted by Adaptix Limited. FDA's decision date was Nov 6, 2025, under product code IZF (System, X-Ray, Tomographic).

Who makes the Adaptix Ortho350?

Adaptix Limited, based in Oxford, is the applicant of record for K252133.

How long did the K252133 review take?

FDA received the submission on Jul 7, 2025 and issued its decision on Nov 6, 2025, 122 days later.

← All decisions in November 2025