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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 / K260855

510(k) cleared

Profoject Safety Pen Needles

CMT Health PTE., Ltd. · Jun 10, 2026 · K260855

FDA cleared the Profoject Safety Pen Needles from CMT Health PTE., Ltd. on Jun 10, 2026 under K260855, a traditional 510(k). The device falls under product code FMI, Needle, Hypodermic, Single Lumen, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Mar 16, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

CMT Health PTE., Ltd. has 8 other decisions in the tracker over the last 12 months: K261372 (Profoject LOR Syringe), K262215 (Profoject Safety Sliding Blood Collection Set), K261829 (Profoject Dual-Safety Pen Needles), K260739 (Profoject Pen Needles (Model A; Model B)).

Questions & Answers

What did FDA clear under K260855?

K260855 is the FDA 510(k) for Profoject Safety Pen Needles, submitted by CMT Health PTE., Ltd.. FDA's decision date was Jun 10, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Profoject Safety Pen Needles?

CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K260855.

How long did the K260855 review take?

FDA received the submission on Mar 16, 2026 and issued its decision on Jun 10, 2026, 86 days later.

← All decisions in June 2026