FDA cleared the Profoject Low Dead Space Syringe /Profoject Tuberculin Syringe; Profoject Low Dead Space Syringe with Needle /Profoject Tuberculin Syringe with Needle; Profoject Low Dead Space Syringe with Permanent Needle /Profoject Tuberculin Syringe with Permanent Needle; Profoject Low Dead Space Safety Syringe /Profoject Tuberculin Safety Syringe from CMT Health PTE., Ltd. on Feb 19, 2026 under K252814, a traditional 510(k). The device falls under product code QNQ, Low Dead Space Piston Syringe, 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 4, 2025. The decision came 168 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).