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MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD vs Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.: FDAPulse comparison

MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD's review days of 154 is 1.3x Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.'s 119 (57th percentile). MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD is dated 2026-09-17; Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. 2026-10-14.

Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)

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How does MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD compare to Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.?

FieldMOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHDSterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.
Record510(k) clearance510(k) clearance
510(k) numberK261266K262042
DeviceMOWANA™ Auto DuoSterilization Cassette (CASS-1)
ApplicantPENTAMASTER MEDIQ SDN BHDAlliedstar Medical Equipment Co., Ltd.
Specialty / panelGeneral HospitalGeneral Hospital
Product codeFMIKCT
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-04-162026-06-17
Decision date2026-09-172026-10-14
Review time (days)154119
Third-party reviewYesNo
Applicant locationSimpang Ampat, MYZiyang, CN
amount percentile57th44th
Predicate Speed & CAPA Advisory Opportunity Score47/10036/100
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Official records: MOWANA™ Auto Duo (K261266): 510(k) cleared for PENTAMASTER MEDIQ SDN BHD · Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.

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Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.

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