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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Medium-Term Adjunctive Predictive Cardiovascular Indicator
510(k) Number K260008
Device Name Deterioration Index Version 2
Applicant
Epic Systems Corporation
1979 Milky Way
Verona,  WI  53593
Applicant Contact Brian Jacobson
Correspondent
Epic Systems Corporation
1979 Milky Way
Verona,  WI  53593
Correspondent Contact Melissa Knox
Regulation Number870.2210
Classification Product Code
QNL  
Date Received01/02/2026
Decision Date 09/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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