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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 / July 2026 / K261829

510(k) cleared

Profoject Dual-Safety Pen Needles

CMT Health PTE., Ltd. · Jul 29, 2026 · K261829

FDA cleared the Profoject Dual-Safety Pen Needles from CMT Health PTE., Ltd. on Jul 29, 2026 under K261829, 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 Jun 2, 2026. The decision came 57 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), K260739 (Profoject Pen Needles (Model A; Model B)), K260514 (Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle).

Questions & Answers

What did FDA clear under K261829?

K261829 is the FDA 510(k) for Profoject Dual-Safety Pen Needles, submitted by CMT Health PTE., Ltd.. FDA's decision date was Jul 29, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Profoject Dual-Safety Pen Needles?

CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K261829.

How long did the K261829 review take?

FDA received the submission on Jun 2, 2026 and issued its decision on Jul 29, 2026, 57 days later.

← All decisions in July 2026