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The Tracker / September 2026 / K261266

510(k) cleared

MOWANA Auto Duo

PENTAMASTER MEDIQ SDN BHD · Sep 17, 2026 · K261266

FDA cleared the MOWANA Auto Duo from PENTAMASTER MEDIQ SDN BHD on Sep 17, 2026 under K261266, a traditional 510(k) reviewed through the Third Party Review Program. 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 Apr 16, 2026. The decision came 154 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for PENTAMASTER MEDIQ SDN BHD in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261266?

K261266 is the FDA 510(k) for MOWANA Auto Duo, submitted by PENTAMASTER MEDIQ SDN BHD. FDA's decision date was Sep 17, 2026, under product code FMI (Needle, Hypodermic, Single Lumen).

Who makes the MOWANA Auto Duo?

PENTAMASTER MEDIQ SDN BHD, based in Simpang Ampat, is the applicant of record for K261266.

How long did the K261266 review take?

FDA received the submission on Apr 16, 2026 and issued its decision on Sep 17, 2026, 154 days later.

← All decisions in September 2026