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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 / May 2026 / K260792

510(k) cleared

AerFrame Patient Immobilization System (AFPIS)

Stabilix, LLC · May 8, 2026 · K260792

FDA cleared the AerFrame Patient Immobilization System (AFPIS) from Stabilix, LLC on May 8, 2026 under K260792, a traditional 510(k). The device falls under product code IYE, Accelerator, Linear, Medical, regulated at 21 CFR 892.5050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Mar 11, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Stabilix, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260792?

K260792 is the FDA 510(k) for AerFrame Patient Immobilization System (AFPIS), submitted by Stabilix, LLC. FDA's decision date was May 8, 2026, under product code IYE (Accelerator, Linear, Medical).

Who makes the AerFrame Patient Immobilization System (AFPIS)?

Stabilix, LLC, based in Dallas, TX, is the applicant of record for K260792.

How long did the K260792 review take?

FDA received the submission on Mar 11, 2026 and issued its decision on May 8, 2026, 58 days later.

← All decisions in May 2026