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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 / February 2026 / K253068

510(k) cleared

Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe

CMT Health PTE., Ltd. · Feb 23, 2026 · K253068

FDA cleared the Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe from CMT Health PTE., Ltd. on Feb 23, 2026 under K253068, a traditional 510(k) reviewed through the Third Party Review Program. 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 Sep 22, 2025. The decision came 154 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), 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 K253068?

K253068 is the FDA 510(k) for Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe, submitted by CMT Health PTE., Ltd.. FDA's decision date was Feb 23, 2026, under product code FMF (Syringe, Piston).

Who makes the Profoject Insulin Syringes; Profoject Safelock Disposable Insulin Syringe?

CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K253068.

How long did the K253068 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Feb 23, 2026, 154 days later.

← All decisions in February 2026