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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 / August 2026 / K251641

510(k) cleared

GF-310R Multigas Unit (GF-310R)

Nihon Kohden Corporation · Aug 12, 2026 · K251641

FDA cleared the GF-310R Multigas Unit (GF-310R) from Nihon Kohden Corporation on Aug 12, 2026 under K251641, a traditional 510(k). The device falls under product code CCK, Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, regulated at 21 CFR 868.1400 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on May 29, 2025. The decision came 440 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nihon Kohden Corporation has 2 other decisions in the tracker over the last 12 months: K260747 (YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff), K251366 (EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)).

Questions & Answers

What did FDA clear under K251641?

K251641 is the FDA 510(k) for GF-310R Multigas Unit (GF-310R), submitted by Nihon Kohden Corporation. FDA's decision date was Aug 12, 2026, under product code CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase).

Who makes the GF-310R Multigas Unit (GF-310R)?

Nihon Kohden Corporation, based in Tokyo, is the applicant of record for K251641.

How long did the K251641 review take?

FDA received the submission on May 29, 2025 and issued its decision on Aug 12, 2026, 440 days later.

← All decisions in August 2026

Sources