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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K261913

510(k) cleared

X°Port Heart Preservation System

Traferox Technologies, Inc. · Sep 16, 2026 · K261913 · In the directory

FDA cleared the X°Port Heart Preservation System from Traferox Technologies, Inc. on Sep 16, 2026 under K261913, a traditional 510(k). The device falls under product code MSB, System And Accessories, Isolated Heart, Transport And Preservation, regulated at 21 CFR 876.5880 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jun 8, 2026. The decision came 100 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Traferox Technologies, Inc. has 2 other decisions in the tracker over the last 12 months: P250025 (TorEx Lung Perfusion System), K260456 (VI°Port Liver Preservation System).

Questions & Answers

What did FDA clear under K261913?

K261913 is the FDA 510(k) for X°Port Heart Preservation System, submitted by Traferox Technologies, Inc.. FDA's decision date was Sep 16, 2026, under product code MSB (System And Accessories, Isolated Heart, Transport And Preservation).

Who makes the X°Port Heart Preservation System?

Traferox Technologies, Inc., based in Mississauga, is the applicant of record for K261913. The company is listed in the MedDevice Startups directory.

How long did the K261913 review take?

FDA received the submission on Jun 8, 2026 and issued its decision on Sep 16, 2026, 100 days later.

← All decisions in September 2026

Sources

In the startup directory

Traferox Technologies

Respiratory & Sleep · Mississauga, ON