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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 K252306
Device Name Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)
Applicant
Steritec Products
74 Inverness Dr. E.
Engelwood,  CO  80112
Applicant Contact Darshan Yeliyur Siddegowda
Correspondent
Getinge
45 Barbour Pond Dr.
Wayne,  NJ  07470
Correspondent Contact Barb Smith
Classification Product Code
QVB  
Date Received07/24/2025
Decision Date 04/22/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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