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 / January 2026 / K253735

510(k) cleared

AV Vascular

Philips Medical Systems Nederland B.V. · Jan 22, 2026 · K253735

FDA cleared the AV Vascular from Philips Medical Systems Nederland B.V. on Jan 22, 2026 under K253735, a traditional 510(k). The device falls under product code QIH, Automated Radiological Image Processing Software, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Nov 24, 2025. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Philips Medical Systems Nederland B.V. has 8 other decisions in the tracker over the last 12 months: K254205 (Zenition 30), K262330 (dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T), K262294 (dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T), K260207 (Multimodality Simulation Workspace (MM Sim) (v1.0.0)).

Questions & Answers

What did FDA clear under K253735?

K253735 is the FDA 510(k) for AV Vascular, submitted by Philips Medical Systems Nederland B.V.. FDA's decision date was Jan 22, 2026, under product code QIH (Automated Radiological Image Processing Software).

Who makes the AV Vascular?

Philips Medical Systems Nederland B.V., based in Best, is the applicant of record for K253735.

How long did the K253735 review take?

FDA received the submission on Nov 24, 2025 and issued its decision on Jan 22, 2026, 59 days later.

← All decisions in January 2026