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Profoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. vs Glucommander (K261939): 510(k) cleared for Glytec, LLC: FDAPulse comparison

Profoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.'s review days of 151 is 1.3x Glucommander (K261939): 510(k) cleared for Glytec, LLC's 117 (56th percentile). Profoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. is dated 2026-09-25; Glucommander (K261939): 510(k) cleared for Glytec, LLC 2026-10-05.

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

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How does Profoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. compare to Glucommander (K261939): 510(k) cleared for Glytec, LLC?

FieldProfoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd.Glucommander (K261939): 510(k) cleared for Glytec, LLC
Record510(k) clearance510(k) clearance
510(k) numberK261372K261939
DeviceProfoject™ LOR SyringeGlucommander
ApplicantCMT Health PTE., Ltd.Glytec, LLC
Specialty / panelAnesthesiologyAnesthesiology
Product codeCAZNDC
Device class22
Clearance typeTraditionalTraditional
DecisionSubstantially EquivalentSubstantially Equivalent
Received2026-04-272026-06-10
Decision date2026-09-252026-10-05
Review time (days)151117
Third-party reviewNoNo
Applicant locationSingapore, SGGreenville, SC, US
amount percentile56th43rd
Predicate Speed & CAPA Advisory Opportunity Score48/10036/100
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Official records: Profoject™ LOR Syringe (K261372): 510(k) cleared for CMT Health PTE., Ltd. · Glucommander (K261939): 510(k) cleared for Glytec, LLC

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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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