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Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. vs S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda: FDAPulse comparison

S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda's review days of 122 is 1.0x Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.'s 119 (45th percentile). Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. is dated 2026-10-14; S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda 2026-10-22.

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

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How does Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. compare to S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda?

FieldSterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd.S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda
Record510(k) clearance510(k) clearance
510(k) numberK262042K262084
DeviceSterilization Cassette (CASS-1)S.I.N. Instruments Kits
ApplicantAlliedstar Medical Equipment Co., Ltd.S.I.N. Implant System Ltda
Specialty / panelGeneral HospitalGeneral Hospital
Product codeKCTKCT
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-06-172026-06-22
Decision date2026-10-142026-10-22
Review time (days)119122
Third-party reviewNoNo
Applicant locationZiyang, CNSão Paulo, BR
amount percentile44th45th
Predicate Speed & CAPA Advisory Opportunity Score36/10042/100
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Official records: Sterilization Cassette (CASS-1) (K262042): 510(k) cleared for Alliedstar Medical Equipment Co., Ltd. · S.I.N. Instruments Kits (K262084): 510(k) cleared for S.I.N. Implant System Ltda

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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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