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The Tracker / September 2026 / K261372

510(k) cleared

Profoject LOR Syringe

CMT Health PTE., Ltd. · Sep 25, 2026 · K261372

FDA cleared the Profoject LOR Syringe from CMT Health PTE., Ltd. on Sep 25, 2026 under K261372, a traditional 510(k). The device falls under product code CAZ, Anesthesia Conduction Kit, regulated at 21 CFR 868.5140 as a Class 2 device. The review panel was Anesthesiology.

FDA logged the submission as received on Apr 27, 2026. The decision came 151 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: K262215 (Profoject Safety Sliding Blood Collection Set), 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).

Questions & Answers

What did FDA clear under K261372?

K261372 is the FDA 510(k) for Profoject LOR Syringe, submitted by CMT Health PTE., Ltd.. FDA's decision date was Sep 25, 2026, under product code CAZ (Anesthesia Conduction Kit).

Who makes the Profoject LOR Syringe?

CMT Health PTE., Ltd., based in Singapore, is the applicant of record for K261372.

How long did the K261372 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on Sep 25, 2026, 151 days later.

← All decisions in September 2026