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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biological Sterilization Indicator With Indirect Growth Detection
510(k) Number K251559
Device Name InstaTRU Instant Biological Indicator for Steam (IBI-05)
Applicant
True Indicating, LLC
946 Kane St.
Toledo,  OH  43551
Applicant Contact Thomas Riha
Correspondent
True Indicating, LLC
946 Kane St.
Toledo,  OH  43551
Correspondent Contact Thomas Riha
Classification Product Code
QVB  
Subsequent Product Code
FRC  
Date Received05/21/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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