WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

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 / K260739

510(k) cleared

Profoject Pen Needles (Model A; Model B)

CMT Health PTE., Ltd. · Jul 15, 2026 · K260739

FDA cleared the Profoject Pen Needles (Model A; Model B) from CMT Health PTE., Ltd. on Jul 15, 2026 under K260739, 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 6, 2026. The decision came 131 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), K260514 (Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle).

Questions & Answers

What did FDA clear under K260739?

K260739 is the FDA 510(k) for Profoject Pen Needles (Model A; Model B), submitted by CMT Health PTE., Ltd.. FDA's decision date was Jul 15, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Profoject Pen Needles (Model A; Model B)?

CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K260739.

How long did the K260739 review take?

FDA received the submission on Mar 6, 2026 and issued its decision on Jul 15, 2026, 131 days later.

← All decisions in July 2026