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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 / September 2025 / K250464

510(k) cleared

Enlight 2100 (TPL-E2103-0)

Timpel S.A. · Sep 10, 2025 · K250464

FDA cleared the Enlight 2100 (TPL-E2103-0) from Timpel S.A. on Sep 10, 2025 under K250464, a traditional 510(k). The device falls under product code QEB, Ventilatory Electrical Impedance Tomograph, regulated at 21 CFR 868.1505 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Feb 18, 2025. The decision came 204 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 Timpel S.A. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K250464?

K250464 is the FDA 510(k) for Enlight 2100 (TPL-E2103-0), submitted by Timpel S.A.. FDA's decision date was Sep 10, 2025, under product code QEB (Ventilatory Electrical Impedance Tomograph).

Who makes the Enlight 2100 (TPL-E2103-0)?

Timpel S.A., based in São Paulo, is the applicant of record for K250464.

How long did the K250464 review take?

FDA received the submission on Feb 18, 2025 and issued its decision on Sep 10, 2025, 204 days later.

← All decisions in September 2025