WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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 one other decision in the tracker over the last 12 months: K260747 (YP-710T Series NIBP Cuff;YP-840T Series Disposable Cuff).

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