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 / K253096

510(k) cleared

Chartis Precision Catheter

Pulmonx Corporation · Feb 13, 2026 · K253096

FDA cleared the Chartis Precision Catheter from Pulmonx Corporation on Feb 13, 2026 under K253096, a traditional 510(k). The device falls under product code CBI, Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector), regulated at 21 CFR 868.5740 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Sep 23, 2025. The decision came 143 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 Pulmonx Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253096?

K253096 is the FDA 510(k) for Chartis Precision Catheter, submitted by Pulmonx Corporation. FDA's decision date was Feb 13, 2026, under product code CBI (Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)).

Who makes the Chartis Precision Catheter?

Pulmonx Corporation, based in Redwood City, CA, is the applicant of record for K253096.

How long did the K253096 review take?

FDA received the submission on Sep 23, 2025 and issued its decision on Feb 13, 2026, 143 days later.

← All decisions in February 2026