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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 / K260514

510(k) cleared

Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle

CMT Health PTE., Ltd. · Jun 12, 2026 · K260514

FDA cleared the Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle from CMT Health PTE., Ltd. on Jun 12, 2026 under K260514, a traditional 510(k). The device falls under product code FMF, Syringe, Piston, regulated at 21 CFR 880.5860 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Feb 17, 2026. The decision came 115 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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 K260514?

K260514 is the FDA 510(k) for Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle, submitted by CMT Health PTE., Ltd.. FDA's decision date was Jun 12, 2026, under product code FMF (Syringe, Piston).

Who makes the Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle?

CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K260514.

How long did the K260514 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Jun 12, 2026, 115 days later.

← All decisions in June 2026