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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 / June 2026 / K261530

510(k) cleared

iiSure Infusion Set

Deka Research and Development · Jun 3, 2026 · K261530 · In the directory

FDA cleared the iiSure Infusion Set from Deka Research and Development on Jun 3, 2026 under K261530, a special 510(k). The device falls under product code FPA, Set, Administration, Intravascular, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 8, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

Deka Research and Development has one other decision in the tracker over the last 12 months: K261672 (twiist Automated Insulin Delivery (AID) System).

Questions & Answers

What did FDA clear under K261530?

K261530 is the FDA 510(k) for iiSure Infusion Set, submitted by Deka Research and Development. FDA's decision date was Jun 3, 2026, under product code FPA (Set, Administration, Intravascular).

Who makes the iiSure Infusion Set?

Deka Research and Development, based in Manchester, NH, is the applicant of record for K261530. The company is listed in the MedDevice Startups directory.

How long did the K261530 review take?

FDA received the submission on May 8, 2026 and issued its decision on Jun 3, 2026, 26 days later.

← All decisions in June 2026

Sources

In the startup directory

Sequel Med Tech

Diabetes & Metabolic · Manchester, NH