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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 / October 2025 / K252631

510(k) cleared

Profoject Disposable Needle

CMT Health PTE., Ltd. · Oct 16, 2025 · K252631

FDA cleared the Profoject Disposable Needle from CMT Health PTE., Ltd. on Oct 16, 2025 under K252631, 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 Aug 20, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

CMT Health PTE., Ltd. has 7 other decisions in the tracker over the last 12 months: K261829 (Profoject Dual-Safety Pen Needles), 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), K260855 (Profoject Safety Pen Needles).

Questions & Answers

What did FDA clear under K252631?

K252631 is the FDA 510(k) for Profoject Disposable Needle, submitted by CMT Health PTE., Ltd.. FDA's decision date was Oct 16, 2025, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the Profoject Disposable Needle?

CMT Health PTE., Ltd., based in Gateway W., is the applicant of record for K252631.

How long did the K252631 review take?

FDA received the submission on Aug 20, 2025 and issued its decision on Oct 16, 2025, 57 days later.

← All decisions in October 2025