Cleared Traditional

K261266 - MOWANA™ Auto Duo

K261266 is an FDA 510(k) clearance for MOWANA Auto Duo, manufactured by PENTAMASTER MEDIQ SDN BHD. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K261266 · PENTAMASTER MEDIQ SDN BHD · General Hospital
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Sep 2026
Decision
154d
Days
Class 2
Risk

K261266 is an FDA 510(k) clearance for the MOWANA™ Auto Duo. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by PENTAMASTER MEDIQ SDN BHD (Simpang Ampat, MY). The FDA issued a Cleared decision on September 17, 2026 after a review of 154 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all PENTAMASTER MEDIQ SDN BHD devices

FDA 510(k) Submission Details - K261266

510(k) Number K261266 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2026
Decision Date September 17, 2026
Days to Decision 154 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMI Needle, Hypodermic, Single Lumen

All 534
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K261266.
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FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.