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 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), K260739 (Profoject Pen Needles (Model A; Model B)).
Questions & Answers
What did FDA clear under K252814?
K252814 is the FDA 510(k) for 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, submitted by CMT Health PTE., Ltd.. FDA's decision date was Feb 19, 2026, under product code QNQ (Low Dead Space Piston Syringe).
Who makes 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?
CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K252814.
How long did the K252814 review take?
FDA received the submission on Sep 4, 2025 and issued its decision on Feb 19, 2026, 168 days later.