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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 / K252735

510(k) cleared

C-beam

Pulmera, Inc. · May 22, 2026 · K252735

FDA cleared the C-beam from Pulmera, Inc. on May 22, 2026 under K252735, a traditional 510(k). The device falls under product code OWB, Interventional Fluoroscopic X-Ray System, regulated at 21 CFR 892.1650 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Aug 28, 2025. The decision came 267 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 Pulmera, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252735?

K252735 is the FDA 510(k) for C-beam, submitted by Pulmera, Inc.. FDA's decision date was May 22, 2026, under product code OWB (Interventional Fluoroscopic X-Ray System).

Who makes the C-beam?

Pulmera, Inc., based in Palo Alto, CA, is the applicant of record for K252735.

How long did the K252735 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on May 22, 2026, 267 days later.

← All decisions in May 2026