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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Drug Dose
510(k) Number K254102
Device Name Glucommander
Applicant
Glytec, LLC
200 N Main St.
Greenville,  SC  29601
Applicant Contact Robby Booth
Correspondent
Glytec, LLC
200 N Main St.
Greenville,  SC  29601
Correspondent Contact Robby Booth
Regulation Number868.1890
Classification Product Code
NDC  
Date Received12/19/2025
Decision Date 05/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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