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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 / November 2025 / K243131

510(k) cleared

Triathlon Pro

Sigma Biomedical · Nov 7, 2025 · K243131

FDA cleared the Triathlon Pro from Sigma Biomedical on Nov 7, 2025 under K243131, a traditional 510(k). The device falls under product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 30, 2024. The decision came 403 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 Sigma Biomedical in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K243131?

K243131 is the FDA 510(k) for Triathlon Pro, submitted by Sigma Biomedical. FDA's decision date was Nov 7, 2025, under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Who makes the Triathlon Pro?

Sigma Biomedical, based in Sunrise, FL, is the applicant of record for K243131.

How long did the K243131 review take?

FDA received the submission on Sep 30, 2024 and issued its decision on Nov 7, 2025, 403 days later.

← All decisions in November 2025