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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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 7 other decisions in the tracker over the last 12 months: K261829 (Profoject Dual-Safety Pen Needles), K260514 (Profoject Safety Needle; Profoject Syringe with Safety Needle; Profoject Low Dead Space Syringe with Safety Needle), K260855 (Profoject Safety Pen Needles), K253268 (Profoject Enteral/Oral Feeding Syringe; Profoject Reusable Enteral/Oral Feeding Syringe (Model A, Model B); Profoject ENFit Adaptor; Profoject Enteral Feeding Syringes Cap).

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